Biotech and Pharmaceutical, Communication Skills, Cross-Functional, Drug Development, FDA (Food and Drug Administration), Leadership, Regulations, Regulatory Requirements, Regulatory Submissions, Risk Management, Vaccination
LOCATION
Morrisville, NC
POSTED
30+ days ago
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
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.