Regulatory Affairs Director Skills

• Prepared and filed annual and quarterly financial statements with regulatory agencies in three states and the Federal Energy Regulatory Commission.
• Maintained excellent working relationships with regulatory agencies, internal project team members, collaborations/partners.
• Direct interface with international regulatory agencies in order to expedite approval of pending registration.
• Worked closely with local and state law enforcement and/or regulatory agencies.
• Developed Target Product Profile to better communications with regulatory agencies.
• Coordinate activities for paper-based and electronic submissions with regulatory agencies.
• Prepare information or responses as requested by regulatory agencies.
• Interact with regulatory agencies to secure filing approvals.
• Represent the company in meetings with regulatory agencies, trade associations (PHSP Coalition, AHIP, and HPA).
• Maintain an active line of communication with FDA or other regulatory agencies directed at driving corporate goals and company priorities.
• Lead preparations for, and participate in, meetings with regulatory agencies to ensure successful regulatory outcomes.
• Develop strategic regulatory approaches to various regulatory agencies (FDA, NB, HC).
• Established and maintained relationships with regulatory agencies, suppliers, academic partners, and customers.
• Served as primary liaison with the FDA investigators, auditors, and other regulatory agencies.
• Participated in Private Label partner audits and inspections by FDA and other regulatory agencies.
• Interact with U.S. and international regulatory agencies, along with AdvaMed.
• Maintained continuing liaison with the personnel of these regulatory agencies.
• Prepare of submissions, and correspondence to regulatory agencies.
• Championed regional drug regulatory agencies harmonization between WADRAN and EADRAN.

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• Selected by senior leadership to participate in the Abbott Regulatory Council key business initiative program to improve Regulatory Affairs across Abbott.
• Represented Regulatory Affairs on promotional materials review committees, medical information working groups, and scientific exchange review committees.
• Served as primary regulatory affairs leader for registration and compliance of pharmaceuticals and medical devices related to pain relief.
• Manage and oversee all projects assigned to the Regulatory Affairs Department to ensure timely and effective implementation.
• Orchestrated the transition of regulatory responsibilities from external consultants to the newly created Regulatory Affairs Department.
• Defined tracking mechanisms and tools for regulatory affairs projects, resulting in greater efficiency and productivity.
• Direct domestic and international regulatory affairs, clinical research and quality assurance.
• Make recommendation on potential improvements to the Regulatory Affairs department.
• Defined and implemented a comprehensive Corporate & Regulatory Affairs Strategy.
• Developed the Director of Government and Regulatory Affairs position.
• Managed corporate regulatory affairs and compliance personnel.
• Assumed dual executive duties with the assignment of the Regulatory Affairs department in additional to the management of the Materiel department.
• Support administration and maintenance of the document repositories and document control areas of Regulatory Affairs (both paper and electronic).
• Directed the technical, code, and regulatory affairs activities for over thirteen producer and thirty-eight associate members of VSI.
• Project teams typically include sales, marketing, engineering, manufacturing, regulatory affairs, technical service and research.
• Lead the Corporate Regulatory Affairs Division of the Legal Department in a fast-paced, dynamic, results-driven environment.
• Strengthened and grew Regulatory Affairs team to manage unprecedented activity load in the history of the company.
• Provided scientific and regulatory affairs expertise and leadership for Corporate HQ and the North American business unit.
• Assure the proper management, retention, and version control of all applicable Regulatory Affairs documentation.
• Maintain direct management responsibility for the Regulatory Affairs Department and its staff of 8 employees.

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• Maintained regular contact and consulted as required with counsel knowledgeable in FDA regulatory matters.
• Review incoming FDA correspondence and collaborated in the determination of required elements for response.
• Co-authored all US and International regulatory FDA briefing and presentation packages.
• Reviewed and edited clinical protocols and supporting documentation for FDA submissions.
• Directed and provided strategic guidance for regulatory submissions and led FDA liaison activities(average 5-6 meetings/year).
• Review all labeling and informational materials sent to FDA for completeness, truthfulness, and compliance with regulations.
• Research FDA regulations, medical resources, websites and other sources on new products and projects as assigned.
• Attended FDA meetings; Lead FDA liaison, experience with New Drug and Office of Generic Drugs.
• Provide regulatory consultation to other departments, i.e., manufacturing, product compliance based on FDA regulations.
• Assisted in obtaining U.S. FDA approval for API manufacturing facilities in Russia, Poland and South Africa.
• Represented the company during one Federal FDA (QSR/GMP 21CFR 820) and one State FDA inspection.
• Draft drug product labeling based on the reference listed drug (RLD) and FDA requirements.
• Ensured the timely submission of well-organized and scientifically sound Regulatory packages to FDA and NIH OBA.
• Obtained IDE approval from FDA for a clinical trial for a Whole Blood illumination dosing study.
• Reviewed and approved changes to manufacturing processes to ensure compliance with FDA and GMP guidelines.
• Supported four FDA audits as the Supplier Quality Assurance Management Representative with Zero 483's.
• Represented the company during one Federal FDA (QSR/GMP 21 CFR 820) inspection.
• Set up early retrospective clinical trials to satisfy new FDA requirements for implantable products.
• Interacted successfully with federal agencies (FDA, OSHA) during on-site GMP inspections.
• Submitted 2301/2253 pharmaceutical promotional content to the Food and Drug Administration (FDA).

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• Monitored and coordinated contractors/vendors access to ensure compliance company vendor policies and procedures, including insurance requirements to protect the property/company.
• Directed and led company-wide cross-functional process improvement efforts, resulting in establishment of new procedures for communications with health authorities.
• Develop and implement standard operating procedures and guidelines for clinical trials and related activities in the division of cardiology.
• Support the preparation of scientifically sound Regulatory submissions in line with requirements and company policies and procedures.
• Developed standard operating procedures including intervention plans, SQF/BRC procedures, and testing procedures.
• Developed regulatory policies and procedures, including a regulatory compliance function.
• Coordinated legal and contractual procedures with foreign office Managing Directors.
• Maintain a broad knowledge of principles, practices, procedures, laws and regulations to proactively diagnose problems and identify solutions.
• Developed global policies and procedures to define best practices and tools for use in Scientific, Strategic and Tactical Operations.
• Developed Compliance program policies and procedures as a member of the Office of Program Integrity.
• Maintain and revise all departmental policies and procedures.
• Reviewed changes in manufacturing facilities, manufacturing procedures, and analytical methods.
• Obtain or provider interpretative guidance upon request Review and approve external departmental policies, procedures, and manuals, as appropriate.
• Developed Standard Operating Procedures (SOPs) and Working Practices governing review and approval of external communications.
• Maintain working knowledge of laboratory industry compliance, keyindustry topics, procedures, issues and concerns.
• Develop Corporate and Standard Operating Procedures, compliance programs, FMEA, preproduction design assurance programs.
• Create and deliveron-boarding procedures for all new faculty members.

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• Developed Regulatory strategy and provided guidance for expanding existing and new product(s) into international markets.
• Managed regulatory strategy, regulatory risk and attained desired regulatory results in Mid-Atlantic region of US.
• Assisted employees in regional regulatory strategy development and execution.
• Led regulatory strategy for manufacturing transfers.
• Provided Regulatory strategy and support for gene therapy product development in the US, Canada, Europe, and Argentina.
• Developed a 510k Regulatory Strategy that improved the accuracy/response time by 15% and 60% respectively.
• Initiated and led Global Chemical Regulatory Strategy team to quickly react to regional needs.

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• Drug facility registrations and listings for global regulatory health agencies and state licensing, including animal feed transportation taxes.
• Identify global regulatory trends & their implications, taking into consideration the impact on business decisions.
• Analyzed U.S. and global regulatory trends and initiated opportunistic and defensive projects to support business goals.
• Maintained a history of successful interactions with global regulatory authorities.
• Build teams, introduce policies, identify global regulatory requirements and create strategies that align with business priorities and goals.
• Review global Regulatory submissions to ensure they are complete, accurate and consistent with corporate objectives.
• Involved with strategic global regulatory and clinical planning, and successful execution of such planning.
• Major Accomplishments: Built global regulatory team/infrastructure to support diagnostic business PMA approval of a companion diagnostic assay.

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• Review and determine the applicability of supporting documentation for inclusion in Regulatory submissions.
• Oversee in-house and external document publishing activities for paper and electronic submissions.
• Provided support to process solutions in submission capacity assessments for electronic submissions.
• Project Manager for multiple regulatory submissions ongoing with collaborators.
• Provide consultation for international regulatory submissions.
• Direct the planning and preparation US and International Regulatory Submissions (EMA, MCC, WHO, and African Countries).
• Prepare and compile all regulatory submissions for the Company's products.
• Drafted, reviewed and negotiated regulatory submissions to ensure they met appropriatestandards and content requirements.

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• Calculated: Nutritional Facts, LD50, %VOC, Vapor Pressure, %HC, & EU Sensitizer Declarations.
• Manage corporate review and approval of CCDSs, US PIs, EU SmPCs and other regional prescribing information.
• Managed regulatory compliance of EU technical documentation and interfaced with external auditors as a technical documentation subject matter expert.
• Provide regulatory intelligence involving review and interpretation of US and EU regulations and guidelines for internal project teams.
• Prepared new technical documentation for EU, Canada and Australian product registration/submission.
• Coordinated large-scale revision of EU Regulatory submission documentation system.

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• Edited collaborators regulatory filings including Appendix M and initial IND application.
• Compiled IND maintenance submissions (Annual Reports, Information Amendments, etc.).
• Key participant in the development of an IND Best Practices Guidance Document
• Interacted with the Chemistry, Manufacturing, Pharmacology/Toxicology and Clinical departments for IND amendments to FDA.
• Liaised across teams to facilitate required summary documents for IND development and submission.
• Developed and managed a comprehensive regulatory submission tracking system for IND submissions.

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• Served as spokesperson for chemical industry legislative and regulatory advocacy and successfully lobbied legislative and regulatory issues impacting the chemical industry.
• Provide strategic guidance on state and federal telecommunication's regulatory issues.
• Advised executive management on regulatory issues which resulted in creative strategies.
• Synthesized complex regulatory issues and advocated key concerns with MSHA, OSHA, and Congress to communicate key issues.
• Negotiated, coordinated and executed various regulatory issues with RBOC's to include tariff compliance and service fulfillment.
• Advise the Chief Compliance Officer and Senior Management on a broad range of legal and regulatory issues.
• Advised member companies on key technical and regulatory issues affecting the industry.
• Interacted with clients on regulatory issues.
• Coordinated development of "ONE" Sprint business position on all telecommunication regulatory issues.

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• Provided key CMC regulatory advice and strategy for product development projects.
• Worked with Pharmaceutical Development and Clinical Operations to formulate CMC strategy.
• Reviewed/approved product/process changes to ensure compliance with CMC requirements.
• Author and/or provide CMC support for branded and generic applications for market in the United States, Canada, and Europe.
• Develop and leverage RA expertise in both CMC and Regional requirements to guide successful product development strategies and supply chain continuity.
• Manage regulatory projects; determine submission requirements, assess proposed CMC changes for regulatory impact US and Worldwide.
• Compiled and filed 2 CMC Technical Sections in support of NADA for 2 novel drug products.
• Research and interpret relevant precedent and maintain files CMC regulatory development issues for BLA3 toxin.
• Serve as the primary liaison with all external consultants for all regulatory CMC matters.
• Provide advice on Latin America regional RA CMC requirements influencing product strategy.
• Provide regulatory assessments for CMC changes and submit updates as required.
• Prepare CMC responses to health authority questions during development, registration and commercial product lifecycle.

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• Managed all regulatory activity related to worldwide marketing of medical devices, including approvals, compliance and quality systems.
• Developed regulatory and quality strategies for the development and introduction of new medical devices.
• Participated in relevant trade association and HA sponsored meetings on medical devices.
• Implemented the pharmacovigilance ensuring the safety and efficacy of medical devices & pharma products.
• Evaluate the compatibility of trauma reconstructive orthopedic medical devices across multiple device classes and product lines.
• Manage the ever evolving and complex regulatory requirements for medical devices in Latin American countries.

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• Respond to regulatory authorities regarding research protocol modifications and clarifications.
• Function as a direct contact with regulatory authorities to facilitate the prompt review of submissions.
• Respond to any and all question from regulatory authorities.
• Negotiated with state and federal regulatory authorities to define and develop regulations impacting company interests and operations.
• Interact with representatives of domestic and international partners, subsidiaries and international regulatory authorities to discuss regulatory issues and submission requirements.
• Assisted regulatory authorities to resolve product acceptance issues, and resolved potential conflicts between installation codes and UL requirements.

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• Directed research and new product development from concept through initial commercial production for contract manufacturing organization.
• Accomplished high-throughput, lean registrations through standardization of documentation modules into the product development process.
• Created and standardized a feasibility worksheet per new product development idea.
• Facilitate key regional decisions which impact global product development and filing strategies
• Consult on business logistics, infrastructure and product development.
• Propose a regulatory component for each product development plan.
• Managed several New Product Development projects and strategic initiatives.
• Oversee quality-engineering activities on product development teams.
• Managed and directed technical activities including basic research, product development, and support for field Technical Service Group.
• Conceptualized 10 new personal care product ideas and managed 20 new product development projects in personal and pet care.
• Consult on product development issues.
• Provided strategic product development, project planning and regulatory consulting for drugproducts on international teams for various clients.
• Recognize potential regulatory issues in day-to-day activities, from product development through the manufacturing process.
• Support quality and regulatory functions on the Electrotek product development.
• Instituted the Stagegate process for product development/project management, served as project leader for all programs.

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• Created and worked with product team to submit 3 Orphan Drug Designation (ODD) applications that supported NDA submissions.
• Provided regulatory support during the NDA review and approval process through to Commercial launch.
• Led the organization's efforts to compile and submit an NDA in eCTD format.
• Authored analytical sections of the Company's first NDA (unexpected shortage of staff)
• Motivated cross-departmental regulatory compliance by coordinating NDA filing regulatory communications meetings.
• Proofread artworks, labeling components and SPL for NDA, ANDA submission and ensured compliance according to RLD's labeling.

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• Develop and review all curriculum to ensure compliance with federal, state, and local regulatory requirements.
• Drafted and / or reviewed internal controls to ensure compliance with Gaming Regulations.
• Drafted key policies to ensure compliance with applicable laws and regulations.
• Oversee state and federal registrations to ensure compliance.
• Monitored and assessed regulatory and financial risks of FINRA member broker/dealer firms to ensure compliance with regulatory standards and policies.
• Drafted the initial, firm-wide ERISA policy and divisional business procedures to increase awareness of regulatory requirements and ensure compliance.

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