Senior Director, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and manage comprehensive global regulatory strategies for both pipeline and marketed products, overseeing the entire lifecycle from early development to post-approval management.

• Act as the primary regulatory strategist within cross-functional development teams, ensuring alignment of regulatory planning with clinical and commercial goals.

• Deliver regulatory insights and proactive risk assessments to senior leadership, including briefings for the Board when necessary.

• Lead engagements with FDA, EMA, and other global health authorities, covering Type A/B/C meetings, Scientific Advice sessions, and interactions with the Innovation Office.

• Collaborate with Clinical Development on the design of early-stage and registration-enabling trials, including endpoints, patient populations, statistical analysis plans, and labeling implications.

• Review and provide regulatory input on clinical documents such as protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and others.

• Oversee IND/CTA submissions and amendments, as well as manage strategies for responding to clinical holds.

• Direct the planning and execution of BLA/NDA/MAA submissions, including Module 2 summaries and coordinating cross-functional submission teams.

• Supervise significant regulatory filings and post-approval submissions, including Changes Being Effected (CBEs), Prior Approval Supplements (PASs), supplements, and annual reports.

• Establish and uphold submission timelines, resource plans, and readiness frameworks for submissions.

• Ensure compliance with eCTD standards and maintain the submission infrastructure in collaboration with Regulatory Operations.

• Build, mentor, and sustain a high-performing regulatory affairs team.

• Continuously monitor and interpret FDA/EMA guidelines, PDUFA commitments, and developments in international regulations; assess their impact on programs and communicate findings to leadership.

⛳️ Requirements

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field; an advanced degree is preferred.

• Over 12 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industries, or equivalent experience.

• Proven success in leading BLA, NDA, or MAA submissions from inception to approval.

• Extensive knowledge of FDA regulations and guidance, including 21 CFR and ICH guidelines.

• Strong understanding of EMA and other significant regulatory frameworks.

• Demonstrated ability to lead Health Authority meetings and manage complex, high-stakes regulatory interactions.

• Experience in clinical regulatory strategy, encompassing protocol design input, trial design, and endpoint negotiations with regulatory agencies.

• Excellent leadership skills with experience in managing and developing teams of regulatory professionals.

• RAC certification (RAPS) is a plus.

• Experience across multiple therapeutic areas or modalities is desirable.

• Global regulatory experience, including submissions and interactions outside the U.S., is advantageous.

• Previous involvement with Breakthrough Therapy, Fast Track, Accelerated Approval, or other expedited designation programs is preferred.

🏝️ Benefits

• Annual bonus target, contingent on eligibility and other criteria.

• Equity awards and equity incentive plans, subject to eligibility and other requirements.

• 401(k) plan with a generous employer match.

• 12 weeks of paid parental leave.

• Up to 12 weeks of leave for living organ and bone marrow donation.

• Comprehensive health plans including medical, prescription drug, dental, and vision coverage.

• Life insurance and disability benefits.

• Flexible time off policy.

• Annual Winter Holiday shutdown.

• At least 11 paid holidays throughout the year.