Senior Director, Regulatory Affairs
Skills
- Demonstrated experience leading global regulatory strategy for drug development programs.
- Proven track record interacting successfully with FDA and other global Health Authorities.
- Strong knowledge of clinical and nonclinical regulatory requirements and filing preparation.
- Experience preparing IND/CTA and BLA/MAA submissions and briefing documents.
- Ability to lead regulatory meetings and negotiate complex scientific/regulatory issues.
Responsibilities
- Serve as global regulatory lead on cross-functional program teams and provide strategic regulatory direction.
- Prepare, review, and manage global regulatory submissions (IND/CTA, DSURs, PIPs, briefing documents, BLA/MAAs) and responses to Health Authority queries.
- Plan for and conduct meetings with Health Authorities and act as primary liaison to build trusted relationships.
- Identify and resolve complex regulatory issues; provide proactive regulatory intelligence and interpret guidance/regulations.
- Assess and pursue expedited pathways and orphan designations where appropriate (e.g., Fast Track, Breakthrough, PRIME).
- Evaluate regulatory approval pathways, competitive landscape, and labeling precedents to inform strategy.
- Engage external regulatory consultants and manage vendor relationships as needed.
- Support departmental processes, SOPs, regulatory development plans, budgeting, and infrastructure improvements.
Education
- Bachelor's degree required; advanced degree (MS, PharmD, PhD) preferred.
- Relevant scientific, clinical, or regulatory training and continuing education in regulatory affairs preferred.
Benefits
- Competitive salary and equity participation
- Comprehensive health, dental, and vision coverage
- Generous paid time off and flexible remote work policy
- 401(k) or retirement plan options (where applicable)
- Professional development and conference support
- Collaborative, mission-driven company culture
Average salary estimate
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