Executive Director, Regulatory Strategy
discover internationalAndrews Air Force Base, MD
Executive Director, Regulatory Strategy
discover internationalAndrews Air Force Base, MDManager L7
Research and Development in BiotechnologyResearch and Development in the Physical, Engineering, and Life SciencesBiological Product Manufacturing
APPLY NOW (opens in a new tab)About the role:
Discover International is partnering with a global biotechnology company investing in scientific innovation, and we're looking for a seasoned regulatory leader to shape global regulatory strategy across our portfolio. In this role, you'll lead a team of global and regional regulatory professionals and play a central part in unifying regulatory strategy across programs, from first-in-human through post-marketing.
What you'll do:
- Lead regulatory strategy for multiple programs, representing Regulatory on senior cross-functional teams and offering innovative solutions to complex, high-stakes challenges
- Ensure global regulatory strategies align with corporate objectives and are effectively negotiated with health authorities
- Partner with global program leads and regional representatives to deliver unified regulatory input across development, clinical, and commercial strategy
- Contribute to the review, authorship, and quality of regulatory submissions and health authority communications
- Advise senior management on the status of global regulatory strategies, tactics, and practices
- Build project plans and timelines, manage and prioritize staff, and create career growth opportunities for your team
- Influence the regulatory landscape through conferences, agency and industry meetings, committees, and trade associations
- Sponsor continuous improvement of departmental processes and provide recommendations for resource planning
- What you bring
- Bachelor's degree in Biology, Chemistry, or a related discipline
- Typically 15+ years of pharmaceutical or biotech regulatory affairs experience and 7+ years of supervisory or management experience (or an equivalent combination of education and experience)
- Expert knowledge of global, regional, and local regulations and guidance for human pharmaceuticals
- Advanced expertise in building regulatory pathways, assessing proposals, and leading productive health authority interactions
- Strong command of preclinical and clinical requirements, data and protocol analysis, safety reporting, and labeling
- Proven ability to navigate ambiguity, think strategically, and propose innovative solutions
- Excellent written and verbal communication, with the ability to influence at all levels of an organization
- A track record of leading in a matrix environment and developing others through coaching and mentoring
- Curiosity about advances in science, AI, technology, and automation, and sound judgment in adopting new capabilities that improve decision-making and patient outcomes
Matching similar jobs
Level
Manager L7
Location
Andrews Air Force Base, MD
Occupation
Regulatory Affairs Managers
Industry
Research and Development in Biotechnology
Posted
yesterday