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Manager, Science & Regulatory Affairs

The primary purpose of this position is to work with BIO’s Science and Regulatory Affairs team to monitor and manage healthcare regulatory issues of importance to the biotechnology industry.  These issues will be primarily related to activities of the Food and Drug Administration (FDA), but may also include other issues identified as priorities by the BIO Board of Directors.

Responsibilities:

  • Conduct research into scientific and regulatory issues as required, in particular for the Health Section, the Government Relations Department, and the Communications Department.
  • Monitor federal and state regulatory activity of importance to BIO’s healthcare-focused companies.  This may include tracking the development of guidance documents, regulations, and other regulatory initiatives in areas of interest to our companies and seek opportunities for BIO input.  Develop and coordinate the approval of written responses to the docket, and verbally communicate BIO positions to relevant government officials. 
  • Contribute to the planning and hosting of dialog sessions with regulatory agencies on behalf of BIO companies and attend meetings held by federal agencies or hearings on the Hill.
  • Disseminate relevant information on scientific and regulatory issues to other BIO staff and to member companies.  Coordinate and manage the activities of staff level BIO science and regulatory affairs policy committees.  Work with other departments at BIO to translate scientific and regulatory issues into language suitable for infographics and talking point documents.
  • Assist in policy development related to healthcare biotech issues, as assigned.  Such issues may include, for example, FDA Human Drug Review, Cell and Gene Therapies, Real World Evidence, Rare Diseases and Clinical Trials.
  • Contribute to the maintainance and enhancement of the “Health Care” and “Regulatory” sections of BIO’s website, so that these pages provide up-to-date information for members and the public on key developments affecting our industry, and related BIO policy and advocacy.
  • Become familiar with the work of the Health Section as a whole and with BIO’s overall priorities and help to ensure that scientific and regulatory work is well-integrated with other activities at BIO.
  • Handle requests from other BIO staff and BIO members quickly, professionally, and effectively, seeking help and guidance from management as needed. 
  • Back up all other health section staff, as required.  This may include anything from hosting/leading meetings to administrative/clerical tasks when necessary. 
  • Fulfill other duties/projects as assigned.

 

Requirements:

  • Excellent communications skills, including writing and speaking skills
  • Excellent research skills, including problem-solving ability and attentiveness to detail
  • Team player
  • Familiarity with the Microsoft computing environment (for example, Word, Excel, Powerpoint, Explorer).
  • Familiarity with standard office machines
  • Bachelor’s degree required, preferably in science or health policy.
  • Master’s degree preferred, preferably in science or health policy.
  • 2-4 years related experience (for example, work in policy development for a biotech company, trade association, legislative office, or regulatory agency)