Management Consultant jobs at ERM - 14931 jobs

A management consulting and technology firm is seeking a Strategy Insights & Planning Consultant in Boston. The role focuses on delivering high-quality solutions in market access and pricing, requiring strong analytical skills and a client-first mentality. Candidates should have an MBA or PhD, or relevant work experience. This position offers a hybrid working model, emphasizing collaborative efforts and personal development. #J-18808-Ljbffr

A management consulting and technology firm is seeking a Strategy Insights & Planning Consultant in Boston. The role involves analyzing market trends and delivering strategic insights for clients in the pharma sector. Candidates should have an MBA or similar with at least 3 years of relevant experience. ZS offers a hybrid working model and comprehensive benefits to encourage professional growth and well-being. #J-18808-Ljbffr

Senior Manager, Mergers & Acquisitions (exit readiness) Are you ready to make an impact? Our expert and award-winning Mergers & Acquisitions (M&A) practice seeks a Senior Manager to join our rapidly growing Sell‑Side Advisory (SSA) team. WM SSA consultants specialize in exit readiness, advising companies on the strategic and operational factors that can impact a potential recapitalization, financing, or exit to a strategic or financial buyer. WM's model leverages the insights of experienced entrepreneurs, seasoned operators, and veteran deals professionals to proactively identify and act on both risk and opportunity, empowering management with precise coaching, and collaborating with investment banks to refine narratives around technology and operations. In this dynamic role, you will work with our national M&A practice, primarily serving portfolio companies of venture capital and private equity firms. Senior principals/senior managers lead operational and technology assessments in a due diligence context and conduct exit readiness exercises for portfolio company leadership and their investors. You will be an integral part of our team, helping shape our team culture and participating in the entrepreneurial process of growing a rapidly expanding offering (strategy formulation, recruiting, team building, practice development, etc.). Responsibilities Lead Transaction Services teams serving clients across industries (with specific capabilities in mergers & acquisitions), while demonstrating executive presence with C‑level client counterparts and private equity teams Engage stakeholders involved in a sell‑side process, including other advisors, investment banks, private equity or corporate owners, and C‑level client executives Confidently coach client executives on how to articulate value derived from technology and operations and on how to navigate potentially challenging diligence topics Facilitate sell‑side due diligence projects focused on operational and technology strategy, organizational structures/operating models, and current state business processes and supporting technology De‑risk exit processes through sell‑side diligence efforts and development of strategies for critical issue remediation Identify strategic opportunities and quantify potential for value creation Lead engagement teams on transaction advisory, guiding the team to prepare focused request lists/agendas, facilitating client reviews, and accountability for deliverables Enhance methodologies for client delivery and practice innovation Manage project economics including pricing estimates, risk assessments tracking project budgets, creating, and delivering invoices, and managing collection process Business development across investment banks, private equity, and portfolio companies Actively recruit, manage, coach, and retain top quality consultants Qualifications Bachelor's degree or equivalent experience required; advanced degree a plus 8+ years working in roles that emphasize strategy, technology, and/or operations in a team‑based, cross‑functional environment 3+ years of experience in investment banking, corporate development/strategy, entrepreneurship/venture capital if you do not have a consulting or M&A background Excellent critical thinking, oral and written communication skills Comfort leading business development opportunities, externally and across the firm Consulting experience a plus, but not required Experience managing or analyzing P&L statements, and financial modeling skills a plus, but not required Candidates must be eligible to work permanently in the United States without sponsorship Ability to travel up to 50% A commitment to inclusion and diversity, and openness to new ideas and perspectives Based on pay transparency guidelines, the salary range for this role can vary based on your proximity to one of our West Monroe offices (see table below). Information on our competitive total rewards package, including our bonus structure and benefits is here. Individual salaries are determined by evaluating a variety of factors including geography, experience, skills, education, and internal equity. Employees (and their families) are covered by medical, dental, vision, and basic life insurance. Employees are able to enroll in our company's 401k plan, purchase shares from our employee stock ownership program and be eligible to receive annual bonuses. Employees will also receive unlimited flexible time off and ten paid holidays throughout the calendar year. Eligibility for ten weeks of paid parental leave will also be available upon hire date. Seattle or Washington, D.C. $209,800 - $246,800 USD $219,800 - $258,500 USD New York City or San Francisco $229,800 - $270,300 USD A location not listed above $199,800 - $235,000 USD West Monroe is an Equal Employment Opportunity Employer. We believe in treating each employee and applicant for employment fairly and with dignity. We base our employment decisions on merit, experience, and potential, without regard to race, color, national origin, sex, sexual orientation, gender identity, marital status, age, religion, disability, veteran status, or any other characteristic prohibited by federal, state or local law. To learn more about diversity, equity and inclusion at West Monroe, visit ***************************** If you require a reasonable accommodation to participate in our recruiting process, please inquire by sending an email to *************************. If you are based in California, we encourage you to read West Monroe's Notice at Collection for California residents, provided pursuant to the California Consumer Privacy Act (CCPA) and linked here. #J-18808-Ljbffr

At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. AI & Data - AI Strategy - Manager - Oil & Gas Sector The opportunity As part of our growing AI & Data practice, we are seeking a highly experienced Senior Manager to lead enterprise AI strategy and quantitative modeling efforts for our clients in the Oil & Gas sector. This individual will bring deep industry expertise, along with a proven track record of designing and operationalizing responsible, scalable, and value‑aligned AI solutions. You'll lead high‑impact client engagements focused on Generative AI, Agentic AI, MLOps, and AI governance frameworks - driving measurable outcomes in upstream, midstream, and downstream operations. As a Manager in AI Strategy, you will leverage proprietary, industry‑aligned business models and innovative operating model designs to deliver impactful AI investments. You will be responsible for capability assessments, operating model design, product management, governance, and process design, ensuring that AI initiatives align with business strategies and stakeholder needs. Your key responsibilities In this role, you will lead the delivery of complex AI strategies that enhance business effectiveness and efficiency. You will work closely with clients to envision how AI can transform their markets, products, and capabilities. This position offers the opportunity to engage with business and technology leaders, driving strategic programs that significantly impact their operations. Manage engagement delivery, ensuring quality and risk management throughout the project lifecycle. Manage client relationships, focusing on revenue generation and the identification of new opportunities. Manage resource plans and budgets for engagements, ensuring alignment with performance objectives. Define and implement enterprise‑wide AI and quantitative modeling strategy tailored to oil & gas value chains (e.g., asset optimization, drilling, trading, predictive maintenance). Establish AI governance frameworks that ensure responsible AI adoption, ethical use of data, model risk management, and alignment with evolving regulations. Design and operationalize Agentic AI solutions to automate reasoning, planning, and decision‑making tasks in complex environments. Drive the prioritization of AI use cases based on business value, feasibility, and risk, ensuring ROI on AI initiatives. Lead multidisciplinary teams of data scientists, engineers, and consultants to deliver end‑to‑end AI platforms and solutions. Partner with senior business and IT leaders to identify strategic opportunities and shape AI‑enabled business transformation. Implement and scale ModelOps and MLOps practices, ensuring transparency, reproducibility, and monitoring of models in production. Lead AI solution architecture, including hybrid deployments on cloud (e.g. Microsoft Azure, Amazon AWS). Serve as a thought leader in emerging AI technologies, including Generative AI, foundation models, RAG and Agentic AI. Drive internal capability building and innovation in Responsible AI, agentic workflows, and energy sector‑specific solutions. Skills and attributes for success To excel in this role, you will need a blend of technical and interpersonal skills. Your ability to navigate complex challenges and deliver innovative solutions will be crucial. Strong analytical and decision‑making skills to develop solutions to complex problems. Proven experience in managing client relationships and leading teams. Ability to communicate effectively and influence stakeholders at all levels. To qualify for the role, you must have Bachelor's degree required; Master's degree preferred with focus in Computer Science, Applied Math, or related field with prior consulting experience required. 5+ years of experience in technology consulting, digital transformation, or AI‑driven business solutions. 3+ years of leading AI/ML projects, including team management and executive stakeholder engagement. Typically, no less than 5 years of relevant experience. Strong expertise in AI Platforms and Tools. Proficiency in Data Architecture Design and Modelling. Experience in Digital Transformation and IT Effectiveness Assessment. Knowledge of Emerging Technologies and Technology Strategy, Vision, and Roadmap. Ability to build and manage relationships effectively. Strong exposure to oil & gas industry operations, value levers, and use case landscape. Proven success in developing AI strategy and governance models, including frameworks for Responsible AI, risk, and compliance. Hands‑on experience with Generative AI frameworks (e.g., OpenAI, Hugging Face, LangChain, RAG). Experience architecting and scaling MLOps platforms and data science workflows in cloud‑native environments. Proficiency in Python and tools like Pandas, PyTorch, Scikit‑learn, Spark, SQL. Experience with CI/CD, containerization (e.g., Docker, Kubernetes), and MLFlow or similar tools. Strong client‑facing skills with the ability to articulate technical topics to business executives. Ideally, you'll also have Experience in managing change and leading teams. Strong negotiation and influencing skills. Familiarity with sector knowledge and commercial acumen. Prior experience leading AI initiatives in the energy or oil & gas sector, including exploration, refining, or energy trading. Familiarity with agentic AI concepts, cognitive architectures, and autonomous agents. Working knowledge of ESG data, climate risk modeling, and regulatory trends in energy. AI certifications (Microsoft, AWS, NVIDIA, Databricks, or equivalent). Exposure to agile delivery models and design thinking approaches. What we look for We seek individuals who are not only skilled but also passionate about driving innovation and transformation through AI. Top performers are those who can think critically, solve complex problems, and communicate effectively with diverse stakeholders. If you are eager to make a significant impact and thrive in a collaborative environment, we want to hear from you! What we offer you At EY, we'll develop you with future‑focused skills and equip you with world‑class experiences. We'll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more . We offer a comprehensive compensation and benefits package where you'll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $125,500 to $230,200. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $150,700 to $261,600. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. Join us in our team‑led and leader‑enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40‑60% of the time over the course of an engagement, project or year. Under our flexible vacation policy, you'll decide how much vacation time you need based on your own personal circumstances. You'll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well‑being. Are you ready to shape your future with confidence? Apply today. EY accepts applications for this position on an on‑going basis. For those living in California, please click here for additional information. EY focuses on high‑ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi‑disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law. EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY's Talent Shared Services Team (TSS) or email the TSS at ************************** . #J-18808-Ljbffr

At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. Technology - Data and Decision Science - AI Native Engineering AI/Machine Learning Engineer, Manager Consultant The opportunity Our Artificial Intelligence and Data team helps apply cutting edge technology and techniques to bring solutions to our clients. As part of that, you'll sit side-by-side with clients and diverse teams from EY to create a well-rounded approach to advising and solving challenging problems, some of which have not been solved before. No two days will be the same, and with constant research and development, you'll find yourself building knowledge that can be applied across a wide range of projects now, and in the future. You'll need to have a passion for continuous learning, stay ahead of the trends, and influence new ways of working so you can position solutions in the most relevant and innovative way for our clients. You can expect heavy client interaction in a fast-paced environment and the opportunity to develop your own career path for your unique skills and ambitions. In this role, you will research, build, and implement scalable artificial intelligence systems that learn and make predictions tailored to business requirements across various environments, including cloud and on-premises. You will enhance data pipelines and storage, ensuring data is clean, accurate, and optimized for XOps processes. Additionally, you will monitor and evaluate learning processes to continuously improve high-performance models, collaborating with other data and analytics professionals to industrialize analysis into effective analytics solutions. Your key responsibilities As a Manager in AI Native Engineering, you will play a pivotal role in delivering innovative solutions that drive business success. You will work with a wide variety of clients to deliver the latest data science and big data technologies. Your teams will design and build scalable solutions that unify, enrich, and derive insights from varied data sources across a broad technology landscape. You will help our clients navigate the complex world of modern data science, analytics, and software engineering. We'll look to you to provide guidance and perform technical development tasks to ensure data science solutions are properly engineered and maintained to support the ongoing business needs of our clients. You will be joining a dynamic and interdisciplinary team of scientists and engineers who love to tackle the most challenging computational problems for our clients. We love to think creatively, build applications efficiently, and collaborate in both the ideation of solutions and the pursuit of new opportunities. Many on our team have advanced academic degrees or equivalent experience in industry. Your responsibilities will include: Leading workstream delivery and ensuring the effective management of processes and projects. Continuously improving processes by identifying innovative solutions through research and analysis. Managing professional employees and supervising teams to deliver complex technical initiatives, with accountability for performance and results. Engaging actively with clients, participating in daily working sessions, and leading workstreams from planning through execution to closure. Identifying opportunities for additional services and managing engagement economics. Skills and attributes for success To excel in this role, you will need a blend of technical expertise and strong interpersonal skills. This role will work to deliver tech at speed, innovate at scale and put humans at the center. Provide technical guidance and share knowledge with team members with diverse skills and backgrounds. Consistently deliver quality client services focusing on more complex, judgmental and/or specialized issues surrounding emerging technology. Demonstrate technical capabilities and professional knowledge. Learn about EY and its service lines and actively assess and present ways to apply knowledge and services The following attributes will make a significant impact: Proven ability to develop solutions to complex problems and recommend changes to policies and procedures. Strong judgment in selecting methods and techniques for obtaining results. Experience in managing client relationships and delivering high-quality service. Ability to lead teams effectively and manage change within the organization. To qualify for the role, you must have A Bachelor's degree required (4-year degree). 6-10 years of relevant experience of full-time working experience in AI, Data Science, and/or Machine Learning 2-4 years of experience directly managing technical teams Strong skills in Python Ability lead, collaborate, and communicate effectively with diverse, hybrid and global teams Experience designing, building, and maintaining high-impact, high-value production AI/ML solutions on a major cloud platform Proficient in Generative AI models and frameworks (e.g., OpenAI, Dall-e, Langchain, Retrieval Augmented Generation (RAG)) and experienced with ML packages like scikit-learn and PyTorch Experience with natural language processing and deep learning Extensive experience in DevOps tools (GIT, Azure DevOps), Agile methodologies (Jira), and CI/CD pipelines for developing, deploying, and scaling analytical solutions Experience with MLOps and ML workflows, including data ingestion, transformation, and evaluation Experience with model retraining and feedback loop methodologies Experience with model and solution monitoring and reporting Understanding of data structures, data modelling and software engineering best practices Strong foundation in mathematics, statistics, and operations research, with proficiency in data manipulation tools (SQL, Pandas, Spark) and deep learning techniques Excellent communication skills for conveying findings and recommendations, with a willingness to travel for client engagements Skills in Technical Design Optimization Strong relationship-building skills Demonstrated client trust and value Digital fluency and emotional agility Commercial acumen and negotiation skills Proven ability to lead teams and manage change Ideally, you'll also have A deep understanding of and ability to teach concepts, tools, features, functions, and benefits of different approaches to apply them Master's degree Computer Science, Mathematics, Physical Sciences, or other quantitative field Experience working with diverse teams to deliver complex solutions Strong skills in languages beyond Python: R, JavaScript, Java, C++, C Experience fine-tuning Generative AI models Experience in managing complex projects with multiple stakeholders A strong understanding of industry trends and emerging technologies Skills in data visualization and storytelling with data Experience with image processing techniques and/or speech and audio processing and analysis What we look for We seek individuals who are not only technically proficient but also possess the ability to think critically and creatively. Top performers demonstrate a commitment to excellence, a collaborative spirit, and a passion for driving innovation in the field of AI and data science. Your ability to collaborate effectively and communicate with clarity will set you apart as a leader in our team. What we offer you At EY, we'll develop you with future-focused skills and equip you with world-class experiences. We'll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more . We offer a comprehensive compensation and benefits package where you'll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $125,500 to $230,200. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $150,700 to $261,600. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year. Under our flexible vacation policy, you'll decide how much vacation time you need based on your own personal circumstances. You'll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being. Are you ready to shape your future with confidence? Apply today. EY accepts applications for this position on an ongoing basis. For those living in California, please click here for additional information. EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law. EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY's Talent Shared Services Team (TSS) or email the TSS at **************************. #J-18808-Ljbffr

Digital Consulting Associate - Oracle EPM ARCS/FCCS/ePBCS/ePCM page is loaded## Digital Consulting Associate - Oracle EPM ARCS/FCCS/ePBCS/ePCMremote type: Remotelocations: Chicago - 550 Van Burentime type: Full timeposted on: Posted Todayjob requisition id: JR-0013571Huron is a global consultancy that collaborates with clients to drive strategic growth, ignite innovation and navigate constant change. Through a combination of strategy, expertise and creativity, we help clients accelerate operational, digital and cultural transformation, enabling the change they need to own their future. Join our team as the expert you are now and create your future.### ### An indispensable role… Our clients approach us with a unique set of complex challenges to forge strategy and operations with technology. So, we are constantly on the look-out for outstanding consultants with varying types of expertise and knowledge who are passionate about uncovering, untangling, and tackling the biggest challenges facing the industry. Our capable Associates utilize Huron tools, methodologies and best practices in the selection, planning and implementation of leading enterprise software and analytics solutions. Skilled relationship builders, our Associates are responsible for project work stream delivery, work plan management, analytics, reporting and client interface/presentations. They collaborate with client staff and leadership while managing and mentoring junior Huron staff. Our Associates gain valuable, hands-on consulting experience and world-class training and development…that translates to career growth. Huron is big enough to offer the opportunity and exposure you need for your career growth-but small enough to give you individual attention for your professional development. We see what's possible in you and help you achieve it.### **Qualifications:*** Bachelor's or Master's degree in a field related to this position or equivalent work experience* 2-4 years of experience in analyzing requirements, writing functional specifications, conducting tests, troubleshooting issues and interfacing with business users* At least 2 years' experience with Oracle EPM ARCS, FCCS, ePCM, and/or Planning* Technical implementation experience with cloud-based Oracle EPM suite: Oracle EPM ARCS, FCCS, ePCM, and/or Planning. TRCS a plus, but not required.* Strong analytical skills used to translate information from meetings into documentation that can be shared with meeting participants and project teams* Effective oral and written communication skills* Ability to own project workstreams through self-discipline for planning and organizing tasks with little to no supervision* A desire and willingness to learn new tools, techniques, concepts, and methodologies* Strong attention to detail, with a quality-focused mindset* Aptitude for, and enjoyment of working in teams* Willingness to travel up to 50% as needed to work with client or other internal project teams* Flexible living locations in the U.S.The estimated base salary range for this job is $105,000 - $130,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron's annual incentive compensation program, which reflects Huron's pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $117,600 - $153,400. The job is also eligible to participate in Huron's benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future.### ## ****Position Level****Associate### ## ****Country****United States of AmericaAt Huron, we're redefining what a consulting organization can be. We go beyond advice to deliver results that last. We inherit our client's challenges as if they were our own. We help them transform for the future. We advocate. We make a difference. And we intelligently, passionately, relentlessly do great work…together. Whether you have years of experience or come right out of college, we invite you to explore our many opportunities. Find out how you can use your talents and develop your skills to make an impact immediately. Learn about how our culture and values provide you with the kind of environment that invites new ideas and innovation. Come see how we collaborate with each other in a culture of learning, coaching, diversity and inclusion. And hear about our unwavering commitment to make a difference in partnership with our clients, shareholders, communities and colleagues. Huron Consulting Group offers a competitive compensation and benefits package including medical, dental, and vision coverage to employees and dependents; a 401(k) plan with a generous employer match; an employee stock purchase plan; a generous Paid Time Off policy; and paid parental leave and adoption assistance. Our Wellness Program supports employee total well-being by providing free annual health screenings and coaching, bank at work, and on-site workshops, as well as ongoing programs recognizing major events in the lives of our employees throughout the year. All benefits and programs are subject to applicable eligibility requirements. Huron is fully committed to providing equal employment opportunity to job applicants and employees in recruitment, hiring, employment, compensation, benefits, promotions, transfers, training, and all other terms and conditions of employment. Huron will not discriminate on the basis of age, race, color, gender, marital status, sexual orientation, gender identity, pregnancy, national origin, religion, veteran status, physical or mental disability, genetic information, creed, citizenship or any other status protected by laws or regulations in the locations where we do business. We endeavor to maintain a drug-free workplace. #J-18808-Ljbffr

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. Principal/Executive Consultant, Quality (Bilingual: Spanish-English) Apply Location Miami, FL Remote Available Posted Oct 3, 2025 At Pharmatech, we bring together the finest minds in life sciences to create innovative strategies for essential and next‑generation medicines and diagnostic tests for the global market. We are an established consultancy that serves the complex needs of pharmaceutical manufacturers and regulated life science companies as they bring innovative new therapies to the market. In 2021, we became the consulting arm of USP (US Pharmacopeia), and we share a common goal of helping manufacturers bring safe, quality medicines and treatments to patients who need them. About the Job: Strong human capital is the lifeblood of our consultancy. Without that, we would not exist. Pharmatech Associates is seeking to add a senior‑level Quality Consultant to our full‑time and/or consulting roster to assist with delivering quality and compliance‑related services. The nature of our projects varies from client to client and can often be supported remotely; however, some may require trips to conduct site visits to locations outside the US. Typical projects include, but are not limited to: Conducting gap assessments of a company's QMS against US FDA requirements with the aim of helping our clients pass a pre‑approval inspection in support of ANDA, NDAs, and BLA submissions, and providing prioritized remediation recommendations Evaluation of inspection readiness programs, including providing recommendations for improvement Remediation planning for various dosage form manufacturing facilities, including oral solid, liquid, and other non‑sterile, as well as sterile, dosage forms Assessment and remediation of laboratory control systems, including data integrity issues Participate in complex root cause investigations, including manufacturing deviations and OOS investigations We will hire someone who is comfortable working remotely, thrives on collaborating with internal and external teams, naturally builds trust and rapport with others, wants to keep others informed of progress, and is willing to adapt and grow as our company grows. We have no bias on your educational background and expect our next addition to be someone with intelligence, self‑awareness, self‑motivation, and ambition. We do expect you to be able to speak to quality considerations and requirements for various product modalities (CGT, mABs, OSD, combination products) across the product development and commercialization life cycle as part of delivering our projects and external thought leadership, and that you can convey that experience succinctly and clearly to our current and future customers. Educational/Experience Requirements include: B.S. in life sciences and 15 years of relevant experience in various quality assurance and quality control roles Demonstrated regulatory compliance expertise in one or more dosage forms as well as both drug products and active pharmaceutical ingredients Expert knowledge of current laws, regulations, and related to gaining approval for manufacturing drug products for the US market Bilingual (Spanish-English) language skills is required Ability to work with a team of consultants and manage work to a defined scope of work and meet timelines Superb written and oral communication skills Excellent interpersonal and soft skills Ability to solve problems using innovative techniques Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Apply Contact Us Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow‑up shortly. ************** ************ #J-18808-Ljbffr

A leading law firm in San Francisco is seeking a Senior Technology Site Reliability Engineering Manager to lead a team focused on ensuring the reliability, scalability, and performance of their infrastructure and services. The ideal candidate will have 7+ years of experience in DevOps or Site Reliability Engineering, strong leadership skills, and proficiency in tools like AWS and Terraform. The firm offers a competitive salary range of $165,000 - $235,000 and comprehensive benefits including 21 days of PTO and parental support. #J-18808-Ljbffr

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. Principal/Executive Consultant, Quality (Bilingual: Spanish-English) Apply Posted Oct 3, 2025 At Pharmatech, we bring together the finest minds in life sciences to create innovative strategies for essential and next-generation medicines and diagnostic tests for the global market. We are an established consultancy that serves the complex needs of pharmaceutical manufacturers and regulated life science companies as they bring innovative new therapies to the market. In 2021, we became the consulting arm of USP (US Pharmacopeia), and we share a common goal of helping manufacturers bring safe, quality medicines and treatments to patients who need them. About the Job Strong human capital is the lifeblood of our consultancy. Without that, we would not exist. Pharmatech Associates is seeking to add a senior-level Quality Consultant to our full-time and/or consulting roster to assist with delivering quality and compliance-related services. The nature of our projects varies from client to client and can often be supported remotely; however, some may require trips to conduct site visits to locations outside the US. Typical projects include, but are not limited to: Conducting gap assessments of a company's QMS against US FDA requirements with the aim of helping our clients pass a pre‑approval inspection in support of ANDA, NDAs, and BLA submissions, and providing prioritized remediation recommendations Evaluation of inspection readiness programs, including providing recommendations for improvement Remediation planning for various dosage form manufacturing facilities, including oral solid, liquid, and other non‑sterile, as well as sterile, dosage forms Assessment and remediation of laboratory control systems, including data integrity issues Participate in complex root cause investigations, including manufacturing deviations and OOS investigations We will hire someone who is comfortable working remotely, thrives on collaborating with internal and external teams, naturally builds trust and rapport with others, wants to keep others informed of progress, and is willing to adapt and grow as our company grows. We have no bias on your educational background and expect our next addition to be someone with intelligence, self‑awareness, self‑motivation, and ambition. We do expect you to be able to speak to quality considerations and requirements for various product modalities (CGT, mABs, OSD, combination products) across the product development and commercialization life cycle as part of delivering our projects and external thought leadership, and that you can convey that experience succinctly and clearly to our current and future customers. Educational/Experience Requirements B.S. in life sciences and 15 years of relevant experience in various quality assurance and quality control roles Demonstrated regulatory compliance expertise in one or more dosage forms as well as both drug products and active pharmaceutical ingredients Expert knowledge of current laws, regulations, and related to gaining approval for manufacturing drug products for the US market Bilingual (Spanish‑English) language skills is required Ability to work with a team of consultants and manage work to a defined scope of work and meet timelines Superb written and oral communication skills Excellent interpersonal and soft skills Ability to solve problems using innovative techniques Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Apply Contact Us Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow‑up shortly. ************** ************ 22320 Foothill Blvd. Suite 330, Hayward CA 94541 #J-18808-Ljbffr

Huron is a global consultancy that collaborates with clients to drive strategic growth, ignite innovation and navigate constant change. Through a combination of strategy, expertise and creativity, we help clients accelerate operational, digital and cultural transformation, enabling the change they need to own their future. Join our team as the expert you are now and create your future. An indispensable role… Our clients approach us with a unique set of complex challenges to forge strategy and operations with technology. So, we are constantly on the look‑out for outstanding consultants with varying types of expertise and knowledge who are passionate about uncovering, untangling, and tackling the biggest challenges facing the industry. Our capable Associates utilize Huron tools, methodologies and best practices in the selection, planning and implementation of leading enterprise software and analytics solutions. Skilled relationship builders, our Associates are responsible for project work‑stream delivery, work plan management, analytics, reporting and client interface/presentations. They collaborate with client staff and leadership while managing and mentoring junior Huron staff. Our Associates gain valuable, hands‑on consulting experience and world‑class training and development…that translates to career growth. Huron is big enough to offer the opportunity and exposure you need for your career growth-but small enough to give you individual attention for your professional development. We see what's possible in you and help you achieve it. Qualifications Bachelor's or Master's degree in a field related to this position or equivalent work experience 2‑4 years of experience with Oracle Cloud implementations in one of the following areas: Oracle HCM ORC - Learning, Recruiting, or Talent modules Experience as a functional application specialist Strong analytical skills used to translate information from meetings into documentation that can be shared with meeting participants and project teams Excellent communication skills - oral and written - and the interpersonal skills needed to quickly establish relationships of trust and collaboration Ability to own project workstreams through self‑discipline for planning and organizing tasks with little to no supervision A desire and willingness to learn new tools, techniques, concepts, and methodologies Strong attention to detail, with a quality‑focused mindset Aptitude for, and enjoyment of working in teams Willingness to travel up to 50% as needed to work with client or other internal project teams Living location can be anywhere within the contiguous 48 states and near a major airport The estimated base salary range for this job is $105,000 - $130,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron's annual incentive compensation program, which reflects Huron's pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $117,600 - $153,400. The job is also eligible to participate in Huron's benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future. Position Level Associate Country United States of America #J-18808-Ljbffr

Huron is a global consultancy that collaborates with clients to drive strategic growth, ignite innovation and navigate constant change. Through a combination of strategy, expertise and creativity, we help clients accelerate operational, digital and cultural transformation, enabling the change they need to own their future. Join our team as the expert you are now and create your future. An indispensable role... Our clients approach us with a unique set of complex challenges to forge strategy and operations with technology. So, we are constantly on the look-out for outstanding consultants with varying types of expertise and knowledge who are passionate about uncovering, untangling, and tackling the biggest challenges facing the industry. Our capable Associates utilize Huron tools, methodologies and best practices in the selection, planning and implementation of leading enterprise software and analytics solutions. Skilled relationship builders, our Associates are responsible for project work stream delivery, work plan management, analytics, reporting and client interface/presentations. They collaborate with client staff and leadership while managing and mentoring junior Huron staff. Our Associates gain valuable, hands-on consulting experience and world-class training and development...that translates to career growth. Huron is big enough to offer the opportunity and exposure you need for your career growth-but small enough to give you individual attention for your professional development. We see what's possible in you and help you achieve it. Qualifications Bachelor's or Master's degree in a field related to this position or equivalent work experience 2-4 years of related experience with cloud implementations in a consulting role specifically within the Payroll module End-to-end project implementation experience in one or more of the following areas: Cloud ERP, EPM, CRM or Data Management solutions. Payroll module experience is a must Excellent communication skills - oral and written - and the interpersonal skills needed to quickly establish relationships of trust and collaboration Willingness to travel up to 50% as needed to work with client or other internal project teams Flexible living locations in the U.S. Preferred Qualifications Testing and modifying Fast Formulas Support existing Fast Formulas including reviewing and resolving issues The estimated base salary range for this job is $105,000 - $130,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron's annual incentive compensation program, which reflects Huron's pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $117,600 - $153,400. The job is also eligible to participate in Huron's benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future. Position and Location Position Level: Associate Country: United States of America #J-18808-Ljbffr

Huron is a global consultancy that collaborates with clients to drive strategic growth, ignite innovation and navigate constant change. Through a combination of strategy, expertise and creativity, we help clients accelerate operational, digital and cultural transformation, enabling the change they need to own their future. Join our team as the expert you are now and create your future. An indispensable role... Our clients approach us with a unique set of complex challenges to forge strategy and operations with technology. So, we are constantly on the look‑out for outstanding consultants with varying types of expertise and knowledge who are passionate about uncovering, untangling, and tackling the biggest challenges facing the industry. Our capable Associates utilize Huron tools, methodologies and best practices in the selection, planning and implementation of leading enterprise software and analytics solutions. Skilled relationship builders, our Associates are responsible for project work stream delivery, work plan management, analytics, reporting and client interface/presentations. They collaborate with client staff and leadership while managing and mentoring junior Huron staff. Our Associates gain valuable, hands‑on consulting experience and world‑class training and development that translates to career growth. Huron is big enough to offer the opportunity and exposure you need for your career growth-but small enough to give you individual attention for your professional development. We see what's possible in you and help you achieve it. Qualifications Bachelor's or Master's degree in a field related to this position or equivalent work experience 2-4 years of experience in analyzing requirements, writing functional specifications, conducting tests, troubleshooting issues and interfacing with business users At least 2 years' experience with ARCS (Account Reconciliations) Technical implementation experience with cloud-based Oracle EPM suite: ARCS and/or FCCS and/or Planning Strong analytical skills used to translate information from meetings into documentation that can be shared with meeting participants and project teams Effective oral and written communication skills Ability to own project workstreams through self-discipline for planning and organizing tasks with little to no supervision A desire and willingness to learn new tools, techniques, concepts, and methodologies Strong attention to detail, with a quality-focused mindset Aptitude for, and enjoyment of working in teams Willingness to travel up to 50% as needed to work with client or other internal project teams Flexible living locations in the U.S. Compensation & Benefits The estimated base salary range for this job is $105,000 - $130,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron's annual incentive compensation program, which reflects Huron's pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $117,600 - $153,400. The job is also eligible to participate in Huron's benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future. Position Level Associate Country United States of America #J-18808-Ljbffr

Huron is a global consultancy that collaborates with clients to drive strategic growth, ignite innovation and navigate constant change. Through a combination of strategy, expertise and creativity, we help clients accelerate operational, digital and cultural transformation, enabling the change they need to own their future. Join our team as the expert you are now and create your future. An indispensable role... Our clients approach us with a unique set of complex challenges to forge strategy and operations with technology. So, we are constantly on the look‑out for outstanding consultants with varying types of expertise and knowledge who are passionate about uncovering, untangling, and tackling the biggest challenges facing the industry. Our capable Associates utilize Huron tools, methodologies and best practices in the selection, planning and implementation of leading enterprise software and analytics solutions. Skilled relationship builders, our Associates are responsible for project work stream delivery, work plan management, analytics, reporting and client interface/presentations. They collaborate with client staff and leadership while managing and mentoring junior Huron staff. Our Associates gain valuable, hands‑on consulting experience and world‑class training and development...that translates to career growth. Huron is big enough to offer the opportunity and exposure you need for your career growth-but small enough to give you individual attention for your professional development. We see what's possible in you and help you achieve it. Qualifications Bachelor's or Master's degree in a field related to this position or equivalent work experience 2-4 years of experience in analyzing requirements, writing functional specifications, conducting tests, troubleshooting issues and interfacing with business users At least 2 years' experience with Profitability & Cost Management Cloud Service (ePCM) Strong analytical skills used to translate information from meetings into documentation that can be shared with meeting participants and project teams Effective oral and written communication skills Ability to own project workstreams through self‑discipline for planning and organizing tasks with little to no supervision A desire and willingness to learn new tools, techniques, concepts, and methodologies Strong attention to detail, with a quality‑focused mindset Aptitude for, and enjoyment of working in teams Willingness to travel up to 50% as needed to work with client or other internal project teams Living location can be anywhere within the contiguous 48 states and near a major airport The estimated base salary range for this job is $95,000 - $130,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron's annual incentive compensation program, which reflects Huron's pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $106,400 - $152,500. The job is also eligible to participate in Huron's benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future. Position Level Associate Country United States of America #J-18808-Ljbffr

Job Title: Lead Business Consultant Job Travel Location(s): # Positions: 1 Employment Type: W2 Candidate Constraints: Duration: Long term # of Layers: Work Eligibility: Key Technology: PBM, KPI, SLA, SLO Job Responsibilities Own the process to perform current state analysis (Validate system's business functionality against business requirements and parallel systems) of large IT systems and identify gaps and challenges. Lead workshops and clearly document gaps and provide actionable recommendations per industry standards. Work together with technical analysts to perform thorough analysis and designs. Lead read out sessions, captures feedback and ensure resolution. Skills and Experience Required Required Demonstrated experience in performing current state analysis of large enterprise IT systems. Strong knowledge of PBM (Pharmacy Business Management) business processes which ensure smooth running for retail store operations. Strong experience defining the metrics KPIs, SLAs, SLOs Demonstrated experience in visualizing business workflows, defining objectives and performing rationalization. Desirable Skills High business process aptitude Excellent team player Excellent communication skills Experience working in onshore/offshore model. Experience maturing operational readiness. #J-18808-Ljbffr

A pharmaceutical consultancy is seeking a Regulatory Consultant/CMC in San Francisco, CA, to lead regulatory strategies for small molecule drug development. The ideal candidate will have a bachelor's degree in Chemistry and at least 10 years of experience in regulatory affairs. Key responsibilities include developing global regulatory strategies, managing submissions, and ensuring compliance with regulations. Excellent communication and collaborative skills are essential for success in this role. #J-18808-Ljbffr

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. Regulatory Consultant/CMC, Small Molecule Posted Jan 19, 2024 At Pharmatech, we bring together the finest minds in life sciences to create innovative strategies for essential and next-generation medicines and diagnostic tests for the global market. We are an established consultancy that serves the complex needs of pharmaceutical manufacturers and regulated life science companies as they bring innovative new therapies to the market. In 2021, we became the consulting arm of USP's (US Pharmacopeia) Global health group, and we share a common goal of helping manufacturers bring safe, quality medicines and treatments to patients who need them. In support of our mission, we are seeking Regulatory Consultants for contract work to support our clients projects. About The Job This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) and clinical aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with stakeholders (e.g., other RA functions, Pharmaceutical Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (e.g., CMC strategy/planning for NMEs), driving global CMC RA related activities and successfully executing regulatory strategies in collaboration with stakeholders. Job Responsibilities Acts as a CMC and clinical SME for SMALL MOLECULE drug development and regulatory elements of the drug development process Acts as regulatory expert by global project teams/task forces and is accountable for recommending global regulatory strategy. Works closely with other individuals/groups within Pharmatech Associates to ensure consistency and to identify options for risk discussions. Requires expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure compliance within the organization. Manages the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with local and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. Oversees global submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs. Provides regulatory guidance for compendial issues, JP/EP/USP and other national compendial monographs, and monograph preparation. Qualifications B.S. in Chemistry or equivalent degree plus 10 years industry experience directly in Regulatory Affairs or in CMC and clinical regulatory or role with regulatory submission responsibilities. Experience with global regulatory aspects of CMC and clinical for cell and gene therapy drug products across multiple dosage forms involving undefined frameworks with technical complexity and broad scope. Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required. Advanced interpersonal written and oral communication skills, as well as advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment Ability to manage complex projects by exercising independent decision making and analytical thinking skills Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance Demonstrated track record for successful Health Authority interactions related to regulatory submissions. Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. #J-18808-Ljbffr

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. We are seeking a highly experienced Regulatory Consultant with deep expertise in Abbreviated New Drug Applications (ANDA) to guide and support our regulatory strategy and submissions. This role is remote. Job Duties Work closely with Pharmatech and our client's executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post‑approval commercialization of the client's product. Lead and manage ANDA preparation, review, and submission processes in compliance with FDA regulations. Develop, lead, and drive the execution of the regulatory strategy from deformulation and the preparation of the QQ report, creation of the ANDA including support of FDA inquiries. Plan and oversee activities in support of all regulatory submissions. Serve as the primary company contact with the US FDA to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for the company. Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development. Strong understanding of the QbR framework and leveraging the FDA's Product Specific Guidance. Participate as part of the internal regulatory team to define and execute the regulatory strategy. Support the preparation of briefing packages and regulatory submission documents as needed, providing insight and expertise. Education and Qualifications Advanced degree from an accredited college or university in science, biomedical engineering, plus a minimum of 10 years of experience in filing global regulatory applications for NDA's, ANDA's, IND's, and BLA's for pharmaceutical and biotech products. Minimum of 10 years of experience with ANDA submissions and FDA regulatory processes. Proven track record of successful ANDA approvals. Strong knowledge of 21 CFR Parts 210, 211, 314, and FDA guidance documents. Proven record in submission of licenses and authorizations for the maintenance of existing products; international registrations and dossiers and execution of regulatory strategies that align with business deliverables. Provide Regulatory Affairs support during internal and external audits. Plan schedules for regulatory deliverables on a project and monitor the project through completion. Responsible for communicating business‑related issues or opportunities to next‑level management. Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Apply #J-18808-Ljbffr

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. We are seeking a highly experienced Regulatory Consultant with deep expertise in 505(b)(2) NDA submissions to guide our regulatory strategy and ensure successful product approvals, this role is remote. Job Duties Work closely with Pharmatech and our client's executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post‑approval commercialization of the client's product. The Regulatory Consultant will provide strategic and tactical regulatory guidance for the preparation, submission, and management of 505(b)(2) NDAs. This role requires extensive FDA regulatory knowledge and the ability to manage complex regulatory projects. Lead and manage 505(b)(2) NDA submissions in compliance with FDA regulations. Provide regulatory strategy for new product development, reformulations, and lifecycle management. Develop, lead, and drive the execution of the regulatory strategy from pre‑IND to launch, commercialization and product lifecycle management. Plan and oversee activities in support of all regulatory submissions. Serve as the primary company contact with the US FDA to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for company. Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development. Experience working with government agencies sponsoring drugs and biologics is highly desirable. Combination Drug and Device regulatory submission experience is a plus. Participate as part of internal regulatory team to define and execute the regulatory strategy. Support the preparation of briefing packages, and regulatory submission documents as needed, providing insight and expertise. Education and Qualifications Advanced degree from accredited college or university in science, biomedical engineering, plus a minimum of 10 years of experience in Filing Global Regulatory Applications for the following registrations NDA's, ANDA's, IND's and BLA's for pharmaceutical and Biotech products. Minimum of 10 years' experience with 505(b)(2) NDA submissions. Strong knowledge of 21 CFR Parts 210, 211, 314, and FDA guidance documents. Proven record in submission of licenses and authorizations for the maintenance of existing products; International registrations and dossiers and execution of regulatory strategies that align with business deliverables. Provide Regulatory Affairs support during internal and external audits. Plans schedules for regulatory deliverables on a project and monitors project through completion. Responsible for communicating business‑related issues or opportunities to next management level. Pharmatech Associates, Inc. providesequal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Contact Us First name * Last name * Email * Check all that apply: CMC and Product Development Regulatory Strategy and Submissions Quality Management Systems Facilities Design and Optimization Commissioning, Qualification, and Validation United States and European Union Market Entry Continuous Manufacturing Modeling as a Service and In Silico Support Due Diligence and Technical Assessments I am not sure yet and would like to talk Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow‑up shortly. ************** ************ #J-18808-Ljbffr

ERM seeks an experienced Managing Consultant, Air Quality to provide technical expertise, project and team management, and business development support for our Air Quality Service Area. This is an excellent opportunity for a senior professional to manage and contribute technically to challenging air quality compliance assurance, permitting, and related compliance projects for technology clients throughout the US, and potentially international locations. The successful candidate will also network with ERM's national air quality technical team to share best practices and consulting opportunities, as you build a rewarding career path with a global environmental leader. ERM's Air Quality & Climate Change technical community pursues and wins highly innovative engagements for the most interesting clients, providing the full breadth of air quality and climate change services. With annual global sales more than $50 million, ERM's Air Quality & Climate Change service area is one of the largest among its peers in our industry and is steadily growing at a double-digit pace. In North America alone, ERM has more than 300 dedicated air quality and climate change professionals. RESPONSIBILITIES: * Manage strategic air permitting evaluations, permit applications and compliance assurance programs for a variety of data center and technology clients with complex technical/regulatory issues. Work closely with clients and develop strong relationships to understand specific processes and develop a permitting and compliance strategy to help clients maintain maximum operating flexibility. Achieve client's expectations for scope, budget, schedule, and quality. * Serve as a technical resource on air quality regulatory compliance and permitting programs, including regulatory analyses of facility operations; major and minor source air permit applications under NSR, PSD, Title V, and state-level regulations; and NESHAP MACT compliance programs. * Interact with local regulators to steward permit application review and issuance. * Build and maintain client relationships that generate repeat business to grow the Air Quality service area. * Prepare technical proposals and participate in business development with existing clients and identified leads. * Capitalize on existing client relationships to expand ERM's profile and market share through a combination of excellence in technical delivery and business development. * Effectively manage project teams (including across multiple ERM offices), including appropriately delegating project assignments to project teams and mentoring junior staff. REQUIREMENTS: * Bachelors or master's degree in chemical, environmental, or mechanical engineering, or related discipline. * 4+ years of air quality compliance and permitting experience, including managing and implementing Clean Air Act programs such as Title V, New Source Review, and MACT. * Effective management of multiple air quality projects and building client relationships that result in repeat business. * Technology sector experience desired specific experience in supporting data center sites a plus. * Excellent communication, interpersonal and analytical skills; experience writing comprehensive technical reports. * This position is not eligible for immigration sponsorship. * Experience working with a variety of permitting agencies across different states and localities. Who We Are: As the largest global pure play sustainability consultancy, we partner with the world's leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today while preserving opportunity for future generations. At ERM we know that creating a diverse, equitable and inclusive work environment is an essential part of making our company a great place to build a career. We also see our diversity as a strength that helps us create better solutions for our clients. Our diverse team of world-class experts supports clients across the breadth of their organizations to operationalize sustainability, underpinned by our deep technical expertise in addressing their environmental, health, safety, risk and social issues. We call this capability our "boots to boardroom" approach for its comprehensive service model that allows ERM to develop strategic and technical solutions that advance objectives on the ground or at the executive level. Please submit your resume and brief cover letter. ERM does not accept recruiting agency resumes. Please do not forward resumes to our jobs alias, ERM employees or any other company location. ERM is not responsible for any fees related to unsolicited resumes. ERM is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Thank you for your interest in ERM! #LI-Hybrid