Associate Director Global Regulatory Strategy

The primary responsibility of this role, as Associate Director Global Regulatory Strategy, is: Acts as the primary interface between Bayer and the local Health Authority.

The incumbent will:

• The position Global Regulatory Strategist (GRS), will function within Radiology and have responsibility for planning and managing global regulatory drug and device activities for assigned projects. This includes achieving submissions and approvals and regulatory activities designed to maintain and optimize the net present value of assigned marketed products
• The position will be responsible for all communications as the primary interface between Bayer with a specified regional Health Authority (FDA) for the assigned products and acts
• Organizes and drives preparations for meetings and teleconferences with local HA officials (FDA)
• The position represents a region (US) on the Global Regulatory Team (GRT) or may assume the Global Lead GRS role and represents GRA on the GPT and may have to lead a GPT
• Develops the local regulatory project goals from development through life cycle. Contribute to global regulatory strategy and project goals and may lead the development of the global regulatory strategy as Global Lead GRS
• Compile and submits regulatory filings including INDs IND amendments, clinical trial applications (CTAs) NDA, sNDA etc.
• Develop submission materials for local HA, guides the review process, checks for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission
• Collects, reviews and analyzes competitor information, local and global Agency guidelines and precedence and provides advice to team with minimal supervision
• Responsible for developing the global target labeling in close cooperation with GPT and GRA Global Labeling
• Provides guidance to other functions / staff to assure clinical trial programs are carried out in accordance with all regulations and applicable Bayer Standard Operating Procedures. Data from these trials should support product registration
• Provide regulatory risk assessment for project on a local basis and possibly global level and is able to support that input based on regulatory precedence and product characteristics
• Coordinates regulatory matters with license partners with the Lead GRS and TA supervisor.
• Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in Life Sciences with 4 years in medical research activities of which 1-3 years includes local/global regulatory experience in related therapeutic area. MS degree with 6 years industry experience of which 1-3 years include local/global regulatory experience. BS degree with 8 years industry experience of which 3-5 years of local/global regulatory experience
• The incumbent must have in-depth knowledge of the region (FDA) regulations on drugs and knowledge of device requirements would be a plus. Familiarity with foreign regulations 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.
• The incumbent should have a working knowledge of medical procedures, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials would be a plus.
• Excellent communication skills, verbal and written, are required.
• The ability to work within a global team framework and a multicultural environment is required
• Strong analytical skills are necessary to interpret regulatory data and make critical decisions. The incumbent will be required to focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure.
• Strong management skills are a plus

All your information will be kept confidential according to EEO guidelines.