Biotech and Pharmaceutical, Communication Skills, Cross-Functional, Drug Development, FDA (Food and Drug Administration), Leadership, Regulations, Regulatory Requirements, Regulatory Submissions, Risk Management, Vaccination
Job Title: Director, Regulatory Affairs
Location: Remote
Duration -3 months
Description:
Provides senior regulatory leadership and strategic guidance to support late-stage clinical development programs, ensuring alignment with global regulatory requirements. Acts as the primary regulatory lead for a fast-paced biotech environment, partnering cross-functionally to drive regulatory strategy through Phase III and preparation for potential registration.
Key Responsibilities:
- Lead global regulatory strategy for Phase III clinical programs, with a focus on vaccines.
- Provide hands-on leadership for regulatory submissions and interactions (e.g., FDA, EMA), including NDA/BLA readiness where applicable.
- Serve as interim Regulatory Affairs Lead, ensuring continuity of ongoing programs and regulatory commitments.
- Advise internal stakeholders on evolving regulatory requirements and risk mitigation strategies.
- Support preparation, review, and delivery of high-quality regulatory documents and submissions.
- Act as key liaison with clinical, CMC, and executive teams in a high-pressure, fast-moving biotech setting.
Qualifications:
- Extensive Regulatory Affairs experience (typically 12–15+ years) in biotech/pharma.
- Proven experience leading global regulatory strategy for Phase III clinical programs.
- Vaccine experience strongly preferred.
- Prior experience with NDA/BLA submissions or late-stage regulatory interactions is a plus.
- Demonstrated ability to operate effectively in fast-paced, high-pressure environments.
- Strong leadership, communication, and stakeholder management skills.
C
Careers Integrated Resources Inc