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Associate Director, Global Regulatory Strategist - Bayer HealthCare Pharmaceuticals
Sep 19
Location: Pine Brook , NJCategories: Pharmaceutical
Website: http://bayerjobs.com
Position Description
The Global Regulatory Strategist role has the responsibility for planning and managing global regulatory drug activities for assigned projects within an specific therapeutic area . This includes achieving submission and approval of new chemical entities and oversight of regulatory activities designed to optimize the net present value of assigned marketed products. Responsible for all communications with a specified regional Health Authority (EU Agencies including EMEA or FDA) for the assigned products. The position represents GRA in the GPT and thus is equivalent in responsibility to a GCL or GPL, the position may include coordination of a team of Global Regulatory Managers.
The holder of this position will have one or several functions assigned:
1. Global Project Team membership (usually one GRS is assigned GPT membership per project). The member of the GPT will be in general co-located with the Project Team. The GRS together with the Global Project Leader and the Global Clinical Leader form the core team driving the development of a specific project.
2. Regional responsibility for a Major Region (EU or US), thus acting as the liaison for the EU or US. A Global Regulatory Manager Strategy can only take the liaison role in the region he/she is located
3. Responsibility for certain submission packages/indications.
Advanced technical degree (Ph.D., M.D., D.V.M. or Pharm.D. in life sciences with 10 years industry experience in medical research activities of which 2 — 5 years include global regulatory experience in related therapeutic area or 5 years of local regulatory experience in a highly drug-related country. Or MS degree with 10 years industry experience or BS degree with 14 years industry experience of which 2 — 5 years of local regulatory experience in a highly drug related country. Must have expert knowledge of the region he / she will be responsible for (EMEA/ FDA regulations on Clinical trials applications and drug approval regulations). A working knowledge of foreign regulations as well as of adverse drug event reporting requirements is also required. In-depth knowledge, domestic and foreign, of clinical trial methodology, clinical auditing procedures, and drug safety data collection is also a plus.
