Regulatory Affairs - (US-MA-Confidential )

Minimum Education: Bachelors
Job Type: Full Time
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Mission Statement:
Reporting to the Chief Medical Officer, the qualified candidate will establish and implement a long-term, world-wide regulatory vision assuring the regulatory viability of drug candidates in development, while forecasting the regulatory environment to identify changes that may impact the Company.

Required Skills
• Provide overall leadership and initiative for regulatory strategies by maintaining an ongoing dialogue with the FDA, and as necessary the EMEA, overseeing regulatory documentation, filings and registration process, and providing regulatory strategic input into development teams.
• Direct all policy development, planning, and implementation; represent the Company to the FDA and other regulatory bodies on matters involving development, manufacture, testing, and distribution of investigational products.
• Dedicated to and responsible for building the regulatory function you will establish the function's overall priorities, objectives, standards, and measures.
• Responsible for regulatory affairs operational capabilities, including filing of INDs, annual reports, adverse event filings, maintenance of documentation (archiving), and other activities required to conduct clinical trials.
• Direct the organization and preparation of product registration dossiers for international registration activities.
Required Experience
• A post-graduate degree and at least 10 years professional experience in technical and regulatory disciplines, including the management of a regulatory function.
• Established credibility and an expert reputation within the profession, the FDA, and other regulatory agencies.
• Experience with multiple prior NDA/BLA filings and approvals.
• A solid basis in scientific approach and an ability to deal with in-depth information from a variety of disciplines, fostering a high degree of scientific credibility with regulatory agencies.