Regulatory Affairs Director

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Regulatory Affairs Director

Healthcare & Life Sciences

$ 114 - $ 117.50 / Hour

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Morrisville, North Carolinapass_calibration

Remote

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Contract/Temporary

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JOB ON CANDIDATE PORTAL

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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,muter 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, w 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 w applicable

Serve as interim Regulatory Affairs Lead, ensuring continuity of ongoing programs and regulatorymitments

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,munication, 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,muter 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 w applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to adecco/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

The California Fair Chance Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers

San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ref: US_EN_9...994