Biotechnology Innovation Organization (BIO) is the world’s 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 biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investors and partnering meetings held around the world.

The primary purpose of the Director of Science & Regulatory Affairs is to support the development and execution of policy initiatives that improve BIO members’ ability to conduct research, development, and gain regulatory approval. The primary focus is on FDA policies while also advocating with scientific and regulatory bodies worldwide to ensure harmonization. Reporting to the Vice President of Science and Regulatory, this position supports BIO committees and working groups to develop policies and responses to government dockets as well as representing BIO before government officials. The position also monitors federal regulatory developments, engages with external stakeholders, and liaises with the FDA, as needed. Additional responsibilities include supporting BIO cross-functional teams, conducting research, and special projects as requested.

Essential Functions

• Support BIO’s Science & Regulatory Affairs initiatives to shape the future of drug development.
• Support key priorities including to include:
• Contributing to policy development on the FDA regulation of the biotechnology industry.
• Enhancing scientific dialogue
• Updating evidence generation
• Advancing specialty areas
• Help facilitate committees, task forces, and working groups of experts to advance regulatory policies, develop position papers, and responses to government dockets. Communicate BIO positions to government officials.
• Monitor and analyze federal regulatory, scientific, and legislative developments impacting BIO members and provide updates to BIO staff and members.
• Engage with external stakeholders (trade associations, think tanks, advocacy groups) on regulatory and scientific issues
• Analyze federal and state government legislative activities for science and regulatory impact.
• Collaborate with communications to provide industry updates to members and the public, ensuring alignment of scientific and regulatory efforts with BIO’s broader organizational priorities.
• Provide regular updates at internal BIO meetings, including governance and regulatory committees.

Education and Certifications

• Bachelor’s degree required, Masters preferred

Experience

• 3-5 years of direct involvement in drug development aligned with regulatory or policy development in biopharmaceuticals
• FDA experience strongly preferred
• Demonstrated ability to lead cross-functional initiatives and work collaboratively with internal and external stakeholders to advance regulatory priorities.
• Strong understanding of FDA regulations, healthcare policy, and the biomedical innovation landscape.

Knowledge, Skills, and Abilities

• Knowledge of FDA regulations, drug approval processes, and biotech industry standards.
• Experience supporting policy development and advocating for regulatory changes.
• Strong relationship-building skills.
• Excellent written and verbal skills for drafting policy papers, responses, and presentations.
• Ability to analyze complex regulatory, scientific, and legislative issues.
• Skilled in managing multiple projects, committees, and initiatives.
• Experience working with cross-functional teams.
• Ability to lead teams and manage competing priorities in a dynamic environment.

Physical Requirements

• Sitting/Standing: Remaining in a stationary position for extended periods (sitting at a desk, standing at a counter).
• Reaching: Reaching for items on shelves or in cabinets.
• Lifting/Carrying: Moving boxes, files, or other office equipment up to 15 pounds.
• Using Hands/Fingers: Operating a computer, keyboard, mouse, and other office equipment.
• Vision: Close vision for computer work and detailed tasks.
• Fine Motor Skills: Using a mouse, keyboard, and other small office tools.

Travel Requirements

• 10-15% travel requirements annually

Work Environment

• Hybrid in Office Tuesday-Thursday

This job description is not intended to be all-inclusive, and responsibilities can be expected to evolve over time to meet changing business needs. The employee may be required to perform other related duties to meet these needs. While BIO’s intent is always to be clear and transparent about the expectations of this role, this job description may be reviewed and updated accordingly with or without notice. BIO is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other protected characteristic under federal, state, or local law. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.