Senior Director Regulatory Affairs

Responsibilities:
- Develop, update, and implement a global regulatory strategy supporting product (drugs, biologics, and devices) development, registration, and lifecycle maintenance; integrate strategy into the development plan from candidate selection through end of lifecycle.
- Develop innovative regulatory approaches/solutions, drive acceleration strategies, and identify/effectively communicate regulatory risks.
- Maintain regulatory strategy documentation using expertise and knowledge of regulatory policies, precedents, trends, and emerging regulatory science; integrate external environment inputs, regulator advice, and public information (e.g., Advisory Committees).
- Represent Regulatory Affairs at Regulatory Authority meetings; lead internal cross-functional meeting preparation (topics, meeting requests, briefing packages), negotiate with authority staff, and communicate outcomes/impacts to company leadership.
- Guide CMC, Nonclinical, and Clinical teams on IND/CTA/NDAs-BLAs content and format requirements.
- Conduct nonclinical and clinical GAP analyses for U.S. registration dossiers.
- Support preparation/submission of applications and routine reports/renewals, including supplements and amendments to update investigational/commercial dossiers and labeling.
- Coordinate with third-party contractors to ensure timely preparation/submission of electronic dossiers to health authorities.
- Provide timely communication updates to leadership, program teams, and stakeholders.
- Provide regulatory direction for core data sheet development/amendments and claims mapping aligned to scientific data and regulatory guidance.
- Monitor and assess global regulations/guidance and competitive approvals; continually expand therapeutic area knowledge.
- Partner with Advertising/Promotion Regulatory Scientist and Corporate Communications reviewer as needed; coach/facilitate feedback culture within the Regulatory team.

Minimum Qualifications:
- Advanced scientific degree (PhD, PharmD, MS) with 8+ years industry regulatory affairs/drug development experience; OR Bachelor’s degree with 10+ years.
- Direct experience in clinical regulatory sciences.
- Experience preparing INDs and NDAs/BLAs, supporting CTA/CTNs, and corresponding with U.S. and international health authorities.
- Knowledge of U.S. Federal Regulations for clinical research (21 CFR Parts 50, 56, 312), ICH guidelines, and familiarity with GLP/GMP (21 CFR 58, 210, 211).

Preferred Qualifications:
- Leadership and conflict management; strong communication.
- Experience with regulatory submissions and interactions in the US, EU, and Japan.
- Non-clinical and CMC regulatory science experience; Oncology experience.
- Knowledge of global regulatory procedures and awareness of evolving regulatory reform initiatives.
- Risk assessment/management, attention to detail, negotiation and influence skills.

Benefits:
- Annual bonus, equity compensation, and competitive benefits package.
- Base salary range: $220K–$290K.

Application instructions:
- Not provided in the text.