Executive Director, Regulatory Strategy

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