|
Position Title: Director, Healthcare Regulatory Affairs
Department: Health
Reports to: Executive Vice President, Health
Salary Range: Commensurate w/experience
Primary Purpose of the Position:
The Director, Healthcare Regulatory Affairs, will be responsible for working within the Policy Department to advise BIO and its members on healthcare policy matters including, the development and implementation of strategic BIO responses to key healthcare regulatory and legislative issues identified by the BIO Board, especially including issues - such as vaccines development, bio-defense and any other healthcare policy that the Policy Department faces and that may be assigned.
Requirements:
Strong academic training - minimally a Masters Degree. An MD or PhD in a pertinent health science a significant plus. Solid understanding of the regulatory and legislative process, and specific experience and understanding of FDA regulations and the drug approval process. Experience with the biotechnology industry extremely valuable. Some background with a government regulatory agency, ideally the FDA or CMS, a plus. Awareness of international regulatory issues an advantage. Proven ability and reputation for conceptual thinking Superb communication skills, verbal and written, including public speaking skills Thorough understanding of committee management, including consensus-building skills Highly driven, conscientious and results-oriented, but also pragmatic and flexible Ability to work as part of a team, but balanced by independence, confidence and initiative Willingness to travel as needed
|
Printer Friendly
