Executive Director, Regulatory Affairs

Primary Responsibilities
- Shape and lead comprehensive global regulatory strategy for a program.
- Collaborate on functional strategy; set mid-term goals and strategic priorities aligned to business objectives.
- Provide strategic oversight through regulatory managers/leaders; set tone for feedback-driven, emotionally intelligent leadership.
- Negotiate and influence critical regulatory matters with executive stakeholders.
- Develop and execute corporate regulatory policies.
- Lead interactions with global health authorities (FDA, EMA, and others) and shape regulatory pathway decisions.
- Ensure regulatory compliance throughout the product lifecycle.
- Oversee preparation and submission of major filings (IND, CTA, NDA, BLA, MAA).
- Direct strategy for expedited programs/designations (Fast Track, Orphan Drug, Breakthrough Therapy, RMAT).
- Lead inspections/audits; ensure corrective actions are implemented.
- Mentor and develop the regulatory affairs team; monitor regulatory trends.
- Collaborate cross-functionally for product development and launch.

Education and Skills Requirements
- Bachelor’s degree in life sciences (Master’s preferred).
- 18+ years regulatory affairs; 10+ years in management/leadership.
- Deep regulatory strategy expertise for clinical-stage biotech; strong CTD filing experience.
- Knowledge of FDA/EMA and international rules for clinical, nonclinical, and CMC.
- Experience leading health authority meetings and influencing agency decisions.
- Strong regulatory writing and cross-functional communication; ability to communicate strategy, risks, and mitigation to executives.