Senior Director, Science & Regulatory Affairs
*Biotechnology Innovation Organization (BIO) is the worlds largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products. BIO also produces the BIO International Convention, the worlds largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.*
The primary purpose of this position is to work with BIOs Science and Regulatory Affairs team to lead, 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), 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.
1. 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
* Clinical Trial Modernization
* Regulatory Science
* Preclinical Safety Evaluation
* Pediatric Research
* International Harmonization of Regulatory Requirements
2. Support the Senior Vice President/Vice President, Science and Regulatory affairs in the development and implementation of science and regulatory strategies.
3. Serve as lead staff for assigned Board and staff level Committees and associate policy portfolios.
4. 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.
5. Monitoring federal and state regulatory activity (including the development of new regulations and guidance documents) of importance to BIOs healthcare-focused companies and disseminating relevant information to other BIO staff and to member companies.
6. 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.
7. 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.
8. Conducting research into scientific, regulatory, and legislative issues as required, and disseminating relevant information to other BIO staff and to member companies.
9. 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.
10. Reporting regularly at internal meetings of BIO, including, as required, the BIO Health Section Governing Board, Emerging Companies Section Governing Board, Regulatory Environment Committee, Regulatory Affairs Committee, International Advocacy Steering Committee, Federal Government Relations Committee, and Communications Department.
11. Working with BIO State Government Relations to develop and implementing programs with state-based biotechnology associations to increase understanding and awareness on relevant state legislative issues related to biotechnology in healthcare.
12. Contributing articles to BIO publications, including BIO News and departmental newsletters and blogs. Developing content for BIOs 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.
13. Becoming familiar with the work of the Chief Scientific Officer and health related sections as a whole and with BIOs overall priorities and helping to ensure that scientific and regulatory work is well-integrated with other activities at BIO.
14. 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.
15. Fulfilling other duties/projects as assigned.
*Required Background and skills*
Bachelors degree required, preferably in science or health policy
Masters degree or Ph.D. preferred, preferably in science or health policy
10+ years related experience (for example, work in policy development for a biotech company, trade association, legislative office, or regulatory agency)
_Candidates should be aware that BIO currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date BIO is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law._
Job Type: Full-time
* 401(k) matching
* Dental insurance
* Health insurance
* Health savings account
* Life insurance
* Paid time off
* Parental leave
* Vision insurance
* 8 hour shift
* Monday to Friday
This is a hybrid position. Please see the last paragraph of the job description for information on our our U.S. domestic employee Covid-19 vaccine requirements.
Ability to commute/relocate:
* Washington, DC 20005: Reliably commute or planning to relocate before starting work (Required)
Work Location: One location