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Regulatory Affairs Program Manager Jobs (NOW HIRING)

Hybrid work Job Id: 53583 Regulatory Affairs Senior Manager At Bel, we are not just a company-we are a company on a Mission, built on 160 years of bold innovation, family values, and a commitment to ...

... Regulatory Affairs Manager to ensure Streck remains compliant with all necessary regulatory ... Manage Streck's Risk Management program. * Correspond with Authorized Representatives, Registrars ...

Regulatory Affairs Manager

Schaumburg, IL · On-site

$130K - $150K/yr

Regulatory Affairs Manager Location: Milwaukee, WI (Onsite) Salary: $130,000 - $150,000 Overview We are seeking an experienced Regulatory Affairs Manager to join a growing team supporting regulatory ...

Regulatory Affairs Manager Location: Milwaukee, WI (Onsite) Salary: $130,000 - $150,000 Overview We are seeking an experienced Regulatory Affairs Manager to join a growing team supporting regulatory ...

OR · On-site

Manage regulatory communication strategy for assigned studies * Ensure timely and compliant ... Make a meaningful contribution to clinical programs that put patients first #LI-LB1 EEO Disclaimer ...

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Regulatory Affairs Program Manager information

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

As of Jun 10, 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.
More about Regulatory Affairs Program Manager jobs
What cities are hiring for Regulatory Affairs Program Manager jobs? Cities with the most Regulatory Affairs Program Manager job openings:
What states have the most Regulatory Affairs Program Manager jobs? States with the most job openings for Regulatory Affairs Program Manager jobs include:
Regulatory Affairs Manager

Regulatory Affairs Manager

US Tech Solutions

Lake Forest, IL

Other

Posted 16 days ago


Job description

Company Description

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website www.ustechsolutions.com.

We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well.

Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset.

Job Description
  • Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
  • Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
  • Develop regulatory submission strategies in agreement with defined product development objectives.
  • Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects. Prepare and submit IND and NDA applications, as well as various amendments and supplements.
  • Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
  • Prior management experience, with a demonstrated capability to lead and motivate staff is essential.
  • Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.
Qualifications
  • Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
  • Prepare and submit IND and NDA applications, as well as various amendments and supplements.
Additional Information

Thanks and regards,

Sneha Shrivastava

862 579 4236


US Tech Solutions logo

About US Tech Solutions

Sourced by ZipRecruiter

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

Industry

It services

Company size

1,001 - 5,000 Employees

Headquarters location

Jersey City, NJ, US

Year founded

2000

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