Senior Director of Regulatory Strategy

Job Description

Senior Director, Regulatory Strategy

Washington D.C. - Maryland | Hybrid (3 days onsite)

Discover International is working with a global, science-led biotechnology company to find a Senior Director of Regulatory Strategy. This is a visible leadership position with real influence over how early-stage programs in emerging disease areas, and medicines already on the market, get to patients worldwide.

The Role

You will be accountable for global regulatory strategy across a portfolio of development and commercial programs, from first-in-human studies through post-marketing. You’ll act as the regulatory lead on core development and project teams and serve as the primary strategist for health authority engagement. Depending on the assignment, your remit may be global, regional, or local.

What You’ll Do

• Create and drive global regulatory strategies for multiple or complex programs, captured in Global Regulatory Strategy Documents
• Direct regulatory submission documents and health authority communications across regions
• Represent Global Regulatory Affairs on core development and project teams, working with regional leaders to deliver consistent regulatory input into clinical programs and commercial strategy
• Counsel senior management on the progress of regulatory strategies and tactics, and resolve complex issues with sophisticated regulatory solutions
• Manage project plans, timelines, and resources to keep priorities on track
• Bring matrixed, cross-functional teams into alignment on regulatory requirements, timelines, and deliverables
• Shape the regulatory landscape through participation in conferences, agency and industry meetings, committees, and trade associations
• Monitor regulations, policy, and competitive intelligence, and adapt strategy before changes take effect
• Drive continuous improvement of department processes
• Lead, coach, and develop regulatory team members through skill-building and performance feedback

What You Bring

• Bachelor’s degree in biology, chemistry, or a related field (or an equivalent mix of education and experience)
• At least 12 years in pharmaceutical or biotech regulatory affairs, including 5+ years in a supervisory or management role
• Expert command of global, regional, and local regulations and guidance for human medicines across development, registration, and maintenance
• A track record of building and evaluating proposals to regulatory authorities and leading productive health authority interactions
• Experience advising development teams on refining regulatory pathways as outcomes evolve
• Proven success leading within a matrixed, cross-functional organization
• Strong written, verbal, and presentation skills, with the ability to influence at every level
• A strategic, business-minded approach and a commitment to coaching, mentoring, and inclusive leadership

Nice to Have

• Background in emerging disease areas or lifecycle work on approved medicines
• Active involvement in industry and agency regulatory forums
• Curiosity about AI and new technology, with sound judgment in applying it to improve decisions and efficiency