Adecco Healthcare & Life Sciences is hiring a remote Regulatory Affairs Director for our Pharmaceutical partner in Morrisville, NC.
The anticipated hourly wage for this position is between $114 and $117.50. Hourly wage may depend upon experience, education, geographic location, and other factors.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, Daily Pay, and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria
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 Details: $114.00 to $117.50 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity
Employer/Veterans/DisabledMilitary connected talent encouraged to apply
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