Job Description
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: $210,000.00 - $235,000.00 per year
- Application Question(s):
- - Do you have Regulatory Strategy experience for "Phase III Clinical Programs?"
- Do you possess Vaccines experience?
- Do you Possess CMC and Biotech / Pharma exp. ?
- Experience:
- Regulatory Affairs: 10 years (Required)
- Language:
- Clear English (Required)
Work Location: Remote
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