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Executive Director, Regulatory Strategy

discover internationalAndrews Air Force Base, MD

5 days ago

Occupations

Regulatory Affairs ManagersRegulatory Affairs SpecialistsCompliance Managers

Industries

Research and Development in BiotechnologyResearch and Development in the Physical, Engineering, and Life SciencesBiological Product Manufacturing
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About the role

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

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JOB OVERVIEW

Experience level

Manager

Location

Andrews Air Force Base, MD

Occupation

Regulatory Affairs Managers

Industry

Research and Development in Biotechnology

Posted

5 days ago

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