Executive Director, Regulatory Affairs

Role: Executive Director, Regulatory Affairs (Waltham, MA)

Primary Responsibilities:
- Shape and lead comprehensive global regulatory strategy for a program; align vision with corporate, functional, and program objectives.
- Contribute to functional strategy (mid-term goals, priorities) and ensure execution supports financial and organizational targets.
- Provide strategic oversight through regulatory managers/leaders; drive emotionally intelligent, feedback-driven leadership.
- Partner with executive stakeholders to negotiate and influence key regulatory matters.
- Develop and execute corporate regulatory policies aligned to patient outcomes.
- Lead interactions with global health authorities (FDA, EMA, others); represent the company at strategic meetings.
- Ensure regulatory compliance across the product lifecycle.
- Oversee preparation/submission of INDs, CTAs, NDAs, BLAs, MAAs.
- Direct expedited programs/designations (Fast Track, Orphan Drug, Breakthrough Therapy, RMAT).
- Lead inspections/audits and ensure prompt corrective actions.
- Mentor team; monitor global regulatory trends and guide senior leadership.
- Collaborate cross-functionally for product development and launch.

Education & Skills Requirements:
- Bachelor’s in life sciences or related field (Master’s preferred).
- 18+ years regulatory affairs experience; 10+ years in management/leadership.
- Deep regulatory strategy expertise for clinical-stage biotech; strong CTD filing experience.
- Knowledge of FDA, EMA, and international clinical/nonclinical/CMC regulations.
- Experience leading health authority meetings and negotiating/influencing regulatory decisions.
- Outstanding regulatory writing and executive communication; cross-functional collaboration.

Pay Range: $250,000 - $310,000 USD