Director, Science & Regulatory Affairs

Primary Purpose of the Position:

The primary purpose of this position is to work with BIO’s Science and Regulatory Affairs team to manage and advocate for regulatory policies of importance to the biotechnology industry. These issues will be primarily related to activities of the Food and Drug Administration (FDA) and National Institutes of Health (NIH), but may also include other issues identified as priorities by the BIO Board of Directors. The position requires knowledge of domestic and international regulation of prescription drugs and biologics and strong public policy, analytical, and communications skills. The ability to develop and maintain relationships and to work as part of a team is essential.

Essential Job Duties and Responsibilities:

Developing and proactively advancing BIO regulatory policy initiatives to promote a public policy environment that spurs biomedical innovation. Coordinating all BIO policy development activity related to:

• Drug and Biologic Development & Review
• Clinical Development Modernization
• International Harmonization of Regulatory Requirements

Coordinating working groups of biotechnology company regulatory and technical experts to develop consensus BIO policies and draft position papers. Developing and facilitating approval of written BIO responses to the docket, and verbally communicating BIO positions to relevant government officials.

Monitoring federal regulatory activity (including the development of new regulations and guidance documents) of importance to BIO’s healthcare-focused companies and disseminating relevant information to other BIO staff and to member companies.

Serving as one of the primary BIO liaisons to the FDA. 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.

Engaging with key external stakeholders, including other trade associations, think tanks, advocacy organizations, scientific and professional societies, and public-private partnerships, on regulatory and scientific issues.

Serve as policy support for federal and state government relations teams.

Conducting research into scientific, regulatory, and legislative issues as required, and disseminating relevant information to other BIO staff and to member companies.

Assisting in policy development related to other healthcare biotech issues, as assigned. Such issues may include, for example, FDA human drug review, post-market safety surveillance, product quality and manufacturing, pharmacogenomics, rare disease drug development, and health information technology.

Reporting regularly at internal meetings of BIO, including, as required, the BIO Health Section Governing Board, Regulatory Environment Committee, Regulatory Affairs Committee, Emerging Companies Section Governing Board, International Advocacy Steering Committee, Federal Government Relations Committee, and Communications Department.

Contributing articles to BIO publications. Developing content for BIO’s websites and related social media, to provide up-to-date information for members and the public on key developments affecting our industry, and related BIO policy and advocacy.

Becoming familiar with the work of BIO as a whole and with BIO’s overall priorities and helping to ensure that scientific and regulatory work is well-integrated with other activities at BIO.

Handling requests from other BIO staff and BIO members quickly, professionally, and effectively, seeking help and guidance from management as needed. Backing up all other health section staff, as required. This may include anything from hosting/leading meetings to administrative/clerical tasks when necessary.

Fulfilling other duties/projects as assigned.

Knowledge and Skills Required:

• Excellent communications skills, including writing and speaking skills
• Background in biology, drug development, and the life sciences
• Excellent research skills, including problem-solving ability and attentiveness to detail
• Ability to interact appropriately with senior-level executives and high-ranking public officials
• Ability to multitask on various issues and projects
• Ability to work as part of a team and independently
• Ability to develop and maintain relations with scientific, regulatory, pharmaceutical industry and other allied groups with common interests.
• Familiarity with the Microsoft computing environment (for example, Word, Excel, PowerPoint, Explorer)
• Familiarity with standard office machines

Education and Experience Required:

• Bachelors degree required, preferably in science or health policy
• Masters degree or Ph.D. preferred, preferably in science or health policy
• 5-7+ years related experience (for example, work in policy development for a biotech company, trade association, legislative office, or regulatory agency)