Regulatory Affairs Director

Our client, a leading biotechnology organization specializing in innovative vaccine development, is seeking a Regulatory Affairs Director to join their team. As a Regulatory Affairs Director, you will be part of the Regulatory Affairs Department supporting global clinical development programs. The ideal candidate will demonstrate strategic thinking, strong leadership, and excellent communication skills, which will align successfully in the organization.

Job Title: Regulatory Affairs Director

Location: North Carolina (100% Remote)

Pay Range: $73-117/hr.

Job Type: Contract with the potential to hire

Schedule: support Eastern time zone hours

What's the Job?

• Provide senior regulatory leadership and strategic guidance for late-stage clinical development programs, ensuring compliance with global regulatory requirements.
• Lead global regulatory strategy for Phase III clinical programs, with a focus on vaccines.
• Manage regulatory submissions and interactions with agencies such as FDA and EMA, including NDA/BLA readiness.
• Act as the primary regulatory lead, ensuring continuity of ongoing programs and regulatory commitments.
• Advise internal teams on evolving regulatory landscapes and develop risk mitigation strategies.

What's Needed?

• Extensive Regulatory Affairs experience (typically 12-15+ years) within biotech or pharmaceutical industries.
• Proven experience leading global regulatory strategies for Phase III clinical programs.
• Vaccine experience is strongly preferred.
• Prior experience with NDA/BLA submissions or late-stage regulatory interactions is a plus.
• Strong leadership, stakeholder management, and communication skills, with the ability to operate effectively in fast-paced, high-pressure environments.

What's in it for me?

• Opportunity to lead impactful vaccine development projects in a dynamic biotech environment.
• Collaborate with cross-functional teams and global regulatory agencies.
• Contribute to advancing healthcare solutions on a global scale.
• Work in a supportive and innovative organizational culture.
• Competitive pay rate aligned with industry standards.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.