Associate Director – Regulatory Strategy, Clinical & Nonclinical

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

📋 Description

• Develop and execute comprehensive global regulatory strategies for gene therapy initiatives from preclinical stages through clinical development and commercialization.

• Offer regulatory advice on nonclinical, clinical, and translational development strategies.

• Recognize regulatory risks and suggest mitigation strategies to facilitate program timelines.

• Contribute to the overarching product development strategy and lifecycle planning.

• Oversee the preparation and submission of global regulatory documents including: INTERACT and PreINDs, INDs and IND amendments, CTAs and IMPDs, applications for orphan drug designation, Fast Track, RMAT, and other expedited submissions.

• Ensure the production of high-quality regulatory documentation that meets agency standards.

• Draft regulatory briefing documents and assist in agency meetings.

• Act as a subject matter expert during interactions with regulatory bodies such as the FDA and EMA.

• Organize and draft responses to inquiries and information requests from health authorities.

• Collaborate closely with internal teams including: Clinical Development, Clinical Operations, Nonclinical, and Quality.

• Represent regulatory interests on cross-functional program teams.

• Ensure that development plans are in compliance with global regulatory standards.

• Keep abreast of changing regulations and guidance concerning gene therapies and biologics.

• Interpret guidance documents and relay regulatory expectations within the organization.

• Assist in the development of internal regulatory processes and best practices.

⛳️ Requirements

• PhD, PharmD, MD, or MS in life sciences, molecular biology, pharmacology, or a related field.

• Hands-on experience with AAV, lentiviral, or other gene therapy platforms.

• Knowledge of rare disease development programs.

• Familiarity with global regulatory submissions in both the US and EU.

• Previous involvement in regulatory agency meetings.

• 7–10 years of experience in regulatory affairs within the biotech or pharmaceutical sector (for Associate Director).

• 10–15+ years of regulatory affairs experience demonstrating leadership in regulatory strategy for development programs (for Director).

• Proven track record in leading regulatory submissions and managing agency interactions.

• In-depth understanding of regulatory pathways for biologics and gene therapy products.

• Experience with nonclinical regulatory requirements for biologics.

• Exceptional regulatory writing and communication abilities.

• Capacity to lead cross-functional teams and influence program strategy.

• Strong project management and organizational capabilities.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and career growth.

• Collaborative and innovative work environment.