Director, Regulatory Affairs Strategy

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

📋 Description

• Develop and oversee global regulatory strategies for Phase 2 and Phase 3 clinical development programs.

• Provide regulatory guidance regarding clinical development plans, pivotal trial design, statistical considerations, and registration pathways.

• Assess regulatory risks and opportunities, creating mitigation strategies to support program objectives.

• Direct regulatory planning for key milestones, including End-of-Phase 2 meetings, Scientific Advice procedures, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, and marketing applications.

• Act as the regulatory representative on cross-functional program teams and governance committees.

• Lead the preparation, coordination, and execution of global regulatory agency meetings and interactions.

• Develop briefing documents, regulatory inquiries, meeting strategies, and response packages.

• Represent the organization during regulatory agency meetings and negotiations.

• Ensure alignment of regulatory strategies across regions while addressing local market requirements.

• Supervise the preparation and submission of global regulatory documents, including INDs and IND amendments, Clinical Trial Applications (CTAs), Annual Reports and Development Safety Update Reports (DSURs), Pediatric plans and orphan drug submissions, NDAs, BLAs, MAAs, and other marketing applications.

• Review and approve key submission documents to guarantee regulatory compliance, scientific integrity, and strategic consistency.

• Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to incorporate regulatory considerations into development plans.

• Provide regulatory leadership for label development and commercialization planning.

• Support due diligence activities, business development initiatives, and portfolio evaluations as necessary.

• Mentor and develop regulatory staff, contributing to the enhancement of organizational regulatory capabilities.

• Monitor changes in global regulatory requirements, guidance documents, and industry trends.

• Evaluate the potential impact of regulatory changes on development programs and advise leadership accordingly.

• Ensure compliance with applicable regulatory regulations, guidelines, and company procedures.

⛳️ Requirements

• Bachelor’s degree in a scientific or related field is required.

• A balanced combination of skills and relevant experience will also be considered.

• An advanced degree in Life Sciences, Pharmacy, Medicine, Regulatory Affairs, or a related discipline is preferred (PhD, PharmD, MD, or MS).

• At least 10 years of progressive regulatory affairs experience in the pharmaceutical, biotechnology, or life sciences industry.

• Extensive experience leading regulatory strategy for Phase 2 and Phase 3 development programs.

• Proven success in managing interactions with the FDA and other major global health authorities.

• Experience in supporting or leading NDA, BLA, MAA, or equivalent marketing application submissions.

• Strong understanding of global drug development, regulatory frameworks, and clinical trial regulations.

• Experience in one or more therapeutic areas such as oncology, rare diseases, immunology, neuroscience, or metabolic diseases is preferred.

🏝️ Benefits

• Premium health coverage.

• Financial benefits.

• Work-life balance and well-being offerings for eligible employees and their dependents.

• Wellness and employee support programs.

• Life insurance.

• Disability coverage.

• Retirement plans with employer matching.

• Generous paid time off.