Director, Regulatory Affairs Strategy - Genetics Medicine

About the role

The Director, Regulatory Affairs Strategy will provide leadership on global regulatory activities for assigned products within the Genetic Medicine portfolio. This role is focused on regulatory strategy and filings, with responsibility for providing regulatory leadership across project teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Work Location

Hybrid; 4 days per week on site

Qualifications

• A strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry standard practices
• Demonstrated success leading regulatory strategy and health authority interactions across global programs, with the ability to influence cross-functional teams and senior leadership
• Experience managing or interacting with CROs in the management of ex-US/ex-EU CTAs toward clinical trial activations
• Comfortable operating in ambiguous, fast-paced environments and managing multiple programs and priorities simultaneously
• An MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred
• A minimum of 10 years of pharmaceutical or biotechnology industry experience, with at least 7 years in regulatory affairs, including direct experience as a regulatory liaison

Skills

• Interpretation of regulatory authority feedback, policies, and guidelines
• Leading the development and maintenance of regulatory strategic plans
• Owning the preparation of major clinical submissions required for regulatory approvals
• Working with cross-functional project teams to resolve complex regulatory issues
• Ensuring the quality and timeliness of regulatory submissions for IND/CTA/BLA
• Representing regulatory affairs at senior program team meetings
• Mentoring and developing regulatory staff

Pay

$205,000.00 - $341,600.00 annually

Schedule

Hybrid; 4 days per week on site