Director of Regulatory Affairs - REMOTE

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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