Associate Director Global Regulatory Strategy (RP)

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

The successful candidate will:

•Possess an 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
•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.
• Should have a working knowledge of medical procedures, drug therapy, statistical concepts and the collection of data in clinical trials.

•Excellent verbal and written communication skills are required. Strong management and computerized data collections skills are a plus
•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.

•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 successful candidate will be responsible for all communications as the primary interface between the company with a specified regional health authority for the assigned products and acts
•Organizes and prepares for meetings and teleconferences with local health authorities
•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 health agencies, guides the review process, checks for accuracy, scientific consistency

• Responsible for compliance to local health agency regulations and completeness of submission
•Collects, reviews and analyzes competitor information, local and global agency guidelines and precedence and provides advice to team
•Responsible for developing the global target labeling in close cooperation with GPT and GRA Global Labeling
•Provides guidance to other functions / staff to ensure clinical trial programs meet regulatory compliance standards and the company SOP's.
•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.