Regulatory Affairs Director

Home Regulatory Affairs Director Healthcare & Life Sciences $ 114 - $ 117.50 / Hour location_on Morrisville, North Carolinapass_calibration Remote acute Contract/Temporary favorite_border

JOB ON CANDIDATE PORTAL

COPY LINK link 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.

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