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Job Requirements of Director, Regulatory Affairs:
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Employment Type:
Contractor
-
Location:
North Carolina, US (Onsite)
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Director, Regulatory Affairs
Careers Integrated Resources Inc
North Carolina, US (Onsite)
Contractor
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
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
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