Position Title: Director, Science and Regulatory Affairs
Reports to: Senior Vice President Science and Regulatory Affairs
Primary Purpose of the Position:
The Director, Science and Regulatory Affairs, has responsibility within the Health Section for providing policy development and successful execution of initiatives that improve the ability of BIO companies to conduct research and development and gain regulatory approval of products, both within the United States and internationally. The focus of the position will be primarily to assist in supervising science and regulatory staff level activities relating to the Food and Drug Administration, but will also include advocacy with numerous scientific, regulatory and other bodies both in the United States and abroad.
- Support the Senior Vice President of Science and Regulatory to supervise, build and lead a strong science and regulatory advocacy function with the Health Section
Ensure that BIO identifies current and future scientific and regulatory developments important to BIO Health and Emerging Company Section members, support and engage in advocacy relating to these developments and help ensure BIO achieves its Health and Emerging Company Section goals for scientific and regulatory affairs. Engage company staff, at both the Board and non-Board level, to enable input into policy development and build consensus on BIO’s advocacy activities. Assist in supervising Science and Regulatory activities and staff as they carry out specific activities to develop and achieve the advocacy goals. Track the development of guidance documents, regulations, and other regulatory initiatives in areas of interest to our companies and seek opportunities for BIO input. Coordinate the development and approval of written responses to the docket, and verbally communicate BIO positions to relevant government officials
- Represent BIO externally on science and regulatory biotech issues.
Represent and advocate for BIO at key meetings and with key audiences, which may include the BIO Board of Directors and their lead staff, legislative and executive branch officials, other industry groups, the media, academia, patient advocates, and the public at large. Support the Senior Vice President of Science and Regulatory Affairs in planning and hosting dialog sessions with regulatory agencies on behalf of BIO companies. Maintain and develop new, constructive relationships with potential allies and with pertinent government officials. As appropriate, represent the Executive Vice President for Health and Senior Vice president of Science and Regulatory Affairs in discussing the direction and accomplishments of the Health and Emerging Company Sections generally.
- Provide counsel and serve as a resource within BIO on science and regulatory issues.
Advise the Executive Vice President, Health, the Senior Vice President of Science and Regulatory Affairs and other senior staff on the development and implementation of regulatory policy initiatives. Work collaboratively with other BIO staff, in particular with Government Relations and Legal to help ensure achievement of BIO’s legislative goals, and with Communications to support BIO advocacy generally and to communicate the promise of the science of health biotechnology. Work with other departments at BIO to translate scientific and regulatory issues into language suitable for background and advocacy documents, especially for audiences with no scientific background. Help organize Science and Regulatory tracks at BIO’s annual Convention.
- 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.
- Strong academic training – minimally a Master’s Degree.
- 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.
- 8+ years of work experience
- Some background with a government regulatory agency, ideally the FDA, a plus.
- Awareness of international regulatory issues, an advantage.