Job Details
Posted 30 April, 2026
Job Id: 627623
Clinical and Health – Dir Reg Affairs
Job 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
Pay Rate Range: $70-117/hr depending on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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