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Become A Regulatory Affairs Director

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Working As A Regulatory Affairs Director

  • Evaluating Information to Determine Compliance with Standards
  • Getting Information
  • Communicating with Supervisors, Peers, or Subordinates
  • Communicating with Persons Outside Organization
  • Updating and Using Relevant Knowledge
  • Mostly Sitting

  • $146,100

    Average Salary

What Does A Regulatory Affairs Director Do At Merck

* Build effective partnerships with Merck’s External Manufacturing and External Quality organisations to ensure that there is appropriate CMC engagement and oversight for external manufacturing activity.
* In tandem, ensure that the Site CMC (External) function integrates within the CMC organisation and collaborates effectively with CMC Product leads.
* Together with internal partners, implement practices and processes to ensure that regulatory impacting changes arising from CMOs are appropriately controlled, facilitated and managed to ensure that the company maintains compliance with Marketing Authorizations
* Acts as a point of escalation for regulatory compliance or related issues that may arise at CMOs and a Subject Matter Expert in the management and resolution of any such issues.
* Holds HR and line management responsibilities for the CMC teams (at multiple locations) supporting external manufacture.
* Responsible for managing budget and headcount, hiring, contractor management.
* Manages performance of each of the site teams, ensures that objectives are being met by each team.
* Drives the development and deployment of standard work and best practices across the teams in the key areas of regulatory conformance practice for external manufacturers (change control evaluation, change implementation management, dossier content verification, etc.).
* Represents CMC in External Manufacturing teams of forums

What Does A Regulatory Affairs Director Do At Edwards Lifesciences

* Collaborate on the development of the global regulatory strategy for transcatheter mitral and tricuspid therapies.
* Ensure the strategy’s implementation.
* Partner with the R&D and Clinical Affairs departments in the development and implementation of Mitral and Tricuspid clinical and regulatory strategies to ensure pre-clinical and clinical trials meet appropriate regulatory requirements.
* Interact with the FDA and other approval authorities to negotiate evidence needs, and facilitate global approval of an emerging technology.
* Manage all communications regarding transcatheter mitral and tricuspid therapies with all regulatory agencies; represent the company to agencies and trade associations.
* Hire and develop the Regulatory Affairs team for this new mitral valve initiative; serve as a member of the leadership team for the initiative.
* Facilitate new product development through a committed partnership with R&D, Manufacturing, Marketing and Clinical Affairs throughout all phases of the product development process.
* Effectively manage the Regulatory Affairs team to ensure on-time submissions and approvals that support the mitral and tricuspid therapies initiatives

What Does A Regulatory Affairs Director Do At Glaxosmithkline

* As the Regulatory Affairs Director of Allergy and Smoker’s Health, you will provide regulatory leadership, governance and expertise to the Allergy and Smoker’s Health portfolio of GSK Consumer products such that our products are successfully introduced or maintained Globally.
* In this role, you will build a network of collaborative relationships across the Category and LOCs and will set a compelling vision for the team and deliver against the Category strategy and mission, ensuring all regulatory requirements are met for both innovation and existing products according to GSK Values.
* The Director role requires development of capability and talent within a team of six, as necessary to implement strategy.
* Key Responsibilities:
* Acts as a Business Partner and provides regulatory advice across Category/sub
* Category on all aspects of drug/cosmetic/devices/food and supplements (dependent on category) development and regulatory requirements, both current and future.
* Provides regulatory direction for this significant portfolio of products.
* Develops novel regulatory strategies and influences approaches, in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.
* Communicates, influences and negotiates effectively with cross-functional internal and external groups at all levels.
* Where the role has direct reports, build, maintain and lead an efficient and well-motivated team; ensure effective development, retention and recruitment into the group.
* Ensure appropriate prioritization and resourcing of projects to deliver high quality regulatory files to agreed timelines.
* Leads significant non-product related activities, both in the function and cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.
* Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines.
* May act as GSK representative to external groups for specific topics (e.g.
* AESGP, Cosmetics Europe).
* Ensure the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Copy Review Committee and with senior stakeholders.
* In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
* LI
* GSK
* Why You

What Does A Regulatory Affairs Director Do At Pharmacyclics, LLC

* Serves or manages staff responsible for regulatory advertising and promotion review for assigned products on MARC teams.
* This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance.
* Oversee or manage interactions with OPDP regarding advertising and promotion for assigned products.
* Establishes strong and positive working relationship with OPDP reviewers.
* Applies regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to complex US promotional issues.
* Ensures regulatory compliance while effectively managing business risks.
* Provide promotion integrity advice and guidance on the development of the draft labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based.
* Participates in US labeling negotiations and FDA meetings as necessary.
* Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
* Understands global promotional strategies and provides solution to local US regulatory promotional issues.
* Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
* Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.
* Oversee and manage staff responsible for all operational processes and procedures related to the review/approval of materials with the purpose of promoting, advertising or providing information about the Company and the Company's products.
* Provide educational training for local regulatory staff, contractors and others regarding company policies and procedures within the scope of the Regulatory Affairs Advertising, Promotion.
* Candidate to assist with additional regulatory projects as needed

What Does A Regulatory Affairs Director Do At Cytokinetics

* Formulates regulatory strategies based on current regulatory intelligence
* Oversees implementation of regulatory strategy and activities needed to secure approval of new drugs
* Oversees coordination, preparation and timely submission of regulatory documents
* Maintains current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others as required)
* Provides regulatory advice to other functional areas
* Serves as a principal interface with reviewers from FDA and other health authorities
* Identifies gaps in product development plans that may pose regulatory issues
* Participates in regulatory due diligence activities
* Relationships:Maintains and builds collaborative relationships with partners to improve effectiveness in regulatory
* Develops and maintains cooperative relationships with external vendors and regulatory health authorities
* Coordinates activities for meetings with FDA, EMEA, and other regulatory authorities
* Mentors department personnel and updates appropriate departments on the current regulatory environment
* Management:Supervises employees, consultants/contractors in Regulatory Affairs
* Optimizes employee performance by developing employees and promoting career growth
* Develops and implements regulatory operating guidelines and common work practices/strategies within the team

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Regulatory Affairs Director jobs

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Real Regulatory Affairs Director Salaries

Job Title Company Location Start Date Salary
Regulatory Affairs Director Merck Sharp & Dohme Corp North Wales, PA Mar 11, 2016 $220,667
Director, Corporate Regulatory Affairs, Systems & Standards Hologic, Inc. Marlborough, MA Aug 02, 2016 $190,000
Director, Regulatory Affairs North America Strides Pharma Inc. Lambertville, NJ Jul 10, 2015 $186,035
Director, Regulatory Affairs Lupin Pharmaceuticals, Inc. Baltimore, MD May 01, 2015 $185,000
Director, Regulatory Affairs Lupin Pharmarceuticals, Inc. Baltimore, MD Mar 06, 2016 $185,000
Director, Regulatory Affairs Lupin Pharmarceuticals, Inc. Baltimore, MD Jan 09, 2016 $185,000
Director Regulatory Affairs Roche Molecular Systems, Inc. Pleasanton, CA Jan 15, 2010 $168,000
Director, Drug Regulatory Affairs Hoffmann-La Roche Inc. Nutley, NJ Aug 19, 2011 $164,439
Director, Regulatory Affairs Icon Clinical Research, Inc. MD Nov 14, 2014 $160,000 -
$180,000
Director, Regulatory Affairs Amneal Pharmaceuticals LLC Piscataway, NJ Aug 29, 2016 $158,061
Director of Regulatory Affairs Invagen Pharmaceuticals, Inc. Hauppauge, NY Jun 15, 2014 $142,200
Director, Global Regulatory Affairs Stiefel Laboratories, Inc. Parkton, NC Sep 27, 2012 $136,300 -
$183,250
Director of Regulatory and Scientific Affairs Kerry Inc. South Beloit, IL Sep 06, 2013 $130,000
DIR. Technical & Regulatory Affairs: Environmental Cruise Lines International Association, Inc. Arlington, VA Oct 01, 2012 $130,000
Director of Regulatory Affairs Invagen Pharmaceuticals, Inc. Hauppauge, NY Jun 15, 2011 $100,000
Director, Regulatory Affairs Apicore, LLC Somerset, NJ Jan 31, 2014 $95,400
Regulatory Affairs Director DFW Instrument, LLC Addison, TX Jan 05, 2016 $82,222 -
$104,416

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Top Skills for A Regulatory Affairs Director

RegulatoryComplianceRegulatoryAffairsFDAProductDevelopmentFoodSafetyRegulatoryStrategyProceduresPolicyNDARegulatoryRequirementsRegulatoryIssuesOshaINDAnnualReportsEPADueDiligenceRegulatorySubmissionsCMCISOEU

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Top Regulatory Affairs Director Skills

  1. Regulatory Compliance
  2. Regulatory Affairs
  3. FDA
You can check out examples of real life uses of top skills on resumes here:
  • Reviewed product and company collateral, customer notifications, telemarketing scripts, and sales agent materials for regulatory compliance.
  • Direct domestic and international regulatory affairs, clinical research and quality assurance.
  • Set up early retrospective clinical trials to satisfy new FDA requirements for implantable products.
  • Directed research and new product development from concept through initial commercial production for contract manufacturing organization.
  • Coordinate with Food Safety and other cross-functional partners on ingredient approvals (GRAS/FAP) and uses.

Top Regulatory Affairs Director Employers

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