Vice President, Regulatory Affairs (ex-US) Aegerion Pharmaceuticals, Inc.
Working in a team environment, the Vice President will provide regulatory oversight, support and guidance for all company functions, provide key input to regulatory strategy for products in development and in commercial distribution, and be responsible for planning and coordinating regulatory submissions necessary to support clinical trials, product registration, and postmarketing activities outside of the United States. The Vice President will serve as a principal regulatory affairs liaison to regulatory bodies outside of the US and will also be responsible for advising executive management and other staff on the impact of new regulatory initiatives and changing regulations as they pertain to the company?s research and development programs and commercial operations.
Develop and implement innovative regulatory strategies to support development projects and commercial needs, including life cycle management, for all Aegerion products outside of the US.
Interface directly with government personnel, including scientific reviewers, administrative support and management to facilitate the review and approval of regulatory applications.
Manage the planning and coordination of productive and effective regulatory submissions and regulatory agency meetings.
Work closely with other functional area leaders and across project teams to ensure that all activities are conducted in compliance with relevant ex-US laws, regulations, and guidance. Ensure clear communication of project activities and progress in a timely manner.
Coordinate the preparation and submission of required documents to regulatory agencies. Ensure submissions are complete, properly formatted, and comply with applicable local regulatory requirements.
Develop Requests for Proposal to identify local regulatory consultants when needed.
Make certain that appropriate documentation is maintained to record regulatory decisions for company projects.
Develop and maintain strong and effective relations with internal/external personnel.
Monitor and analyze regulatory agency activities and advise senior management on appropriate action.
Provide leadership on teams and committees in all areas of regulatory affairs.
Build and maintain excellent relationships with regulatory authorities.
Ensure appropriate training and development of staff
Develop departmental budget for all non-US-related regulatory expenses including headcount
Provide ex-US regulatory due diligence assessments of potential acquisitions
Minimum BS in life sciences field.
10-15 years experience in regulatory affairs in various stages of product development, including postmarketing support, in major ex-US territories including EU, LATAM, and Japan/Asia
Experience in various types of interactions with ex-US regulatory authorities.
Experience and knowledge in preparation of CTXs, MAAs, and supportive amendments and supplements. Experience with CTD/eCTD.
Working knowledge of ex-US (EU and/or LATAM and/or Japan) and ICH published regulatory guidance and regulations. Understanding of major regulatory authorities? structure and function (e.g., EMA, ANVISA, ANMAT, COFEPRIS, PMDA).
Knowledge of international GMP, GLP and GCP regulations as well an understanding of the pharmaceutical product life cycle.
Expert knowledge of international regulations and guidelines related to drug development.
Strong negotiation, communication and interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
High degree of cultural competency in Central/South America and/or Europe preferred.
Bilingual or multilingual preferred.
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