VP, Science and Regulatory Affairs

Biotechnology Innovation Organization•Washington, DC

15h•$220,000 - $250,000•Hybrid

About The Position

The Vice President, Science and Regulatory Affairs, develops and executes policy initiatives that improve BIO companies' ability to conduct research, development, and gain regulatory approval domestically and internationally, with primary focus on FDA and NIH policies while also advocating with scientific and regulatory bodies worldwide. Reporting to the Senior Vice President, Science & Regulatory Affairs, this position works collaboratively across BIO departments and member committees to develop strategic Science & Regulatory Affairs priorities, advance BIO's regulatory policy agenda through strategic implementation with measurable success outcomes, and represent BIO in senior-level internal and external meetings to address key regulatory and legislative issues supporting biopharmaceutical development as approved by the BIO Board.

Requirements

Master’s Degree required and experience in relevant area of study strongly preferred
12 or more years of drug development or policy experience with the biopharmaceutical industry, private or non-profit health policy advocacy organization, or a government agency (FDA or NIH)
3 years or more of management experience
Extensive understanding of biopharmaceutical development process and related regulatory and legislative policies and process.
In depth understanding of the regulatory and legislative process, and specific experience and understanding of FDA regulations as well as the drug development and approval process.
Knowledgeable in international policy and regulatory environment
Solid scientific understanding of biotechnology
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

Responsibilities

Work with the Senior Vice President, Science & Regulatory Affairs to build and lead a strong Science and Regulatory Affairs function for BIO
Lead and/or manage Science & Regulatory Committees, Task Force or Work Groups to advance BIO’s science and regulatory agenda.
Ensure that BIO identifies current and future scientific and regulatory developments, develops related advocacy strategies to achieve Board-approved goals
Engage company staff, to provide input and shape BIO positions and advocacy.
Lead, manage and direct Science and Regulatory team staff as they carry out specific activities to develop and achieve advocacy goals.
Oversee the development of guidance documents, regulations, and other regulatory initiatives of priority to BIO.
Represent and advocate for BIO externally at key meetings and with key audiences, which may include the FDA, 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.
Provide counsel and serve as a resource within BIO on science and regulatory issues. Advise BIO staff on regulatory policies and BIO’s policy agenda.
Ensure that Science and Regulatory staff work collaboratively with other BIO staff, 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 prepare and organize for BIO’s International Convention for the Science and Regulatory Affairs department