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Reporting to the Chief Medical Officer, the Head, Regulatory Affairs will establish and implement a long-term, world-wide regulatory vision for Acceleron, assuring the regulatory viability of drug candidates in development, while forecasting the regulatory environment to identify changes that may impact the Company.
Job Responsibilities:
An integral part of the organization, he or she will provide overall leadership and initiative for Acceleron’s 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.
Directing all policy development, planning and implementation, the Head will 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 at Acceleron, the Head will establish the function’s overall priorities, objectives, standards and measures. Further, he or she will be 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. Additionally, the Head will direct the organization and preparation of product registration dossiers for international registration activities.
Required Skills
The Head, Regulatory Affairs will possess a PhD, MD, PharmD or equivalent experience, and at least 10 years professional experience in technical and regulatory disciplines, including the management of a regulatory function. A first-rate manager, he or she must have established credibility and an expert reputation within the profession, the FDA and other regulatory agencies. Further, the Head must have experience with multiple prior NDA/BLA filings and approvals. The Head must also possess experience in directly negotiating the text of product labeling based on data from preclinical trials and obtaining optimal/superior results for the Company. Additionally, he or she must have 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. | | | |
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