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Regulatory Affairs Program Manager Jobs (NOW HIRING)

ImmunityBio

Regulatory Affairs Program Manager

Summit, NJ · On-site

$157K/yr

Position Summary The Regulatory Affairs Program Manager leads crossfunctional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and ...

CNM LLP

Academic Affairs Program Manager

Albuquerque, NM · On-site

$53K - $67K/yr

E07 Position Summary The Academic Affairs Program Manager is responsible for overseeing and ... regulations. * Provides technical or professional coordination and leadership in executing program ...

Unicity

Regulatory Affairs Manager

Provo, UT · On-site

Regulatory Affairs Manager Provo, Utah • In-office About the Company Unicity was founded with a ... and programs that promote metabolic health and improve quality of life. Our person-to-person ...

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How much do regulatory affairs program manager jobs pay per hour?

As of Jul 8, 2026, the average hourly pay for regulatory affairs program manager in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Program Manager, and why are they important?

To thrive as a Regulatory Affairs Program Manager, you need expertise in regulatory guidelines, project management, and a relevant science or healthcare degree. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are highly beneficial. Strong attention to detail, strategic communication, and collaborative problem-solving are crucial soft skills in this role. These competencies ensure efficient navigation of complex regulatory requirements, timely submissions, and successful product approvals.

What is the difference between Regulatory Affairs Program Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Program ManagerRegulatory Affairs Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, regulatory affairs certification (RAC) preferredUsually holds a bachelor’s degree in life sciences or related field; RAC certification is a plus
Work EnvironmentManages multiple projects, oversees teams, and collaborates with cross-functional departmentsFocuses on preparing and submitting regulatory documents, supporting project teams
Employer & Industry UsageUsed in pharmaceutical, biotech, and medical device companies for leadership rolesCommonly employed in similar industries for entry- to mid-level regulatory roles

The Regulatory Affairs Program Manager oversees regulatory strategies and manages teams, while the Regulatory Affairs Specialist handles document preparation and submission. Both roles require relevant credentials and are vital in ensuring compliance within regulated industries.

What are some typical challenges faced by Regulatory Affairs Program Managers when coordinating cross-functional teams?

Regulatory Affairs Program Managers often encounter challenges in aligning the objectives and timelines of different departments such as clinical, quality, and R&D. Balancing varying priorities, managing tight submission deadlines, and ensuring consistent communication between teams are common hurdles. Successful Program Managers proactively foster collaboration, clarify regulatory requirements, and facilitate regular updates to keep projects on track. Being able to anticipate and resolve conflicts, while adapting to evolving regulations, is key to driving effective program execution.

What does a Regulatory Affairs Program Manager do?

A Regulatory Affairs Program Manager oversees and coordinates regulatory activities to ensure that a company's products comply with all applicable laws and regulations. They manage submission processes for product approvals, communicate with regulatory agencies, and develop strategies to maintain compliance throughout the product lifecycle. Additionally, they collaborate with cross-functional teams such as research and development, quality assurance, and manufacturing to align regulatory requirements with business objectives. Their role is crucial in minimizing regulatory risks and accelerating the time to market for new products.
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Regulatory Affairs Program Manager jobs near you

Regulatory Affairs Program Manager

Stark Pharma Solutions Inc

Raynham, MA • On-site

Contractor

Posted yesterday

New

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Regulatory Affairs Program Manager position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Job Title: Regulatory Affairs Program Manager (Medical Device – Divestiture)

Location: Raynham, MA / West Chester, PA / Palm Beach Gardens, FL (Hybrid – 3–4 days onsite)
Duration: 12+ Months (Extension Possible)
 

We are seeking an experienced Regulatory Affairs Program Manager to lead a large-scale Medical Device Divestiture initiative. This role will manage the transfer of global regulatory registrations, submissions, and documentation from a large healthcare organization to a newly established medical device company while ensuring regulatory compliance and seamless execution.

Key Responsibilities:

  • Lead regulatory activities supporting a global divestiture program.
  • Complete and execute the Regulatory Registration Transfer Strategy.
  • Manage ownership transfers, amendments, renewals, notifications, and new submissions.
  • Coordinate with cross-functional Regulatory, Quality, and Project teams.
  • Identify project risks, develop mitigation plans, and ensure GMP compliance.
  • Maintain project documentation, timelines, and stakeholder communication.

Required Skills:

  • 10+ years of Regulatory Affairs experience in the Medical Device industry.
  • Hands-on experience with Divestiture/Business Separation projects.
  • Strong Regulatory Program Management experience.
  • Expertise with FDA 510(k), PMA, global registrations, labeling changes, design changes, and regulatory submissions.
  • Knowledge of registration ownership transfers, submission pathways, and health authority interactions.
  • Excellent communication, leadership, and stakeholder management skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com