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Regulatory Affairs Manager Jobs (NOW HIRING)

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI · On-site

The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...

New

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI · On-site

The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...

Jj

Regulatory Affairs Manager

Raynham, MA

Provide Regulatory Affairs support during internal and external audits * Responsible for communicating business related issues or opportunities to next management level * Responsible for following ...

Dentsply Sirona

Regulatory Affairs Manager

The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team. This role develops regulatory ...

Jj

Regulatory Affairs Manager

West Chester, PA

Provide Regulatory Affairs support during internal and external audits * Responsible for communicating business related issues or opportunities to next management level * Responsible for following ...

McKesson

Regulatory Affairs Manager

Los Angeles, CA

$85K - $141K/yr

We are seeking a Regulatory Affairs Manager. We are seeking a Regulatory Affairs Manager. This is a remote, work-from-home position, preferably based in the Dallas-Fort Worth Metroplex, Texas. Other ...

McKesson

Regulatory Affairs Manager

Concord, NC

$85K - $141K/yr

We are seeking a Regulatory Affairs Manager. We are seeking a Regulatory Affairs Manager. This is a remote, work-from-home position, preferably based in the Dallas-Fort Worth Metroplex, Texas. Other ...

McKesson

Regulatory Affairs Manager

Concord, NC

$85K - $141K/yr

We are seeking a Regulatory Affairs Manager. We are seeking a Regulatory Affairs Manager. This is a remote, work-from-home position, preferably based in the Dallas-Fort Worth Metroplex, Texas. Other ...

Jj

Regulatory Affairs Manager

Palm Beach Gardens, FL

Provide Regulatory Affairs support during internal and external audits * Responsible for communicating business related issues or opportunities to next management level * Responsible for following ...

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How much do regulatory affairs manager jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for regulatory affairs 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 does a regulatory affairs manager do?

A Regulatory Affairs Manager oversees the process of ensuring that a company’s products comply with all regulations and laws applicable to their industry, such as pharmaceuticals, medical devices, or food. They coordinate the preparation and submission of regulatory documents to government agencies and serve as a liaison between the company and regulatory authorities. Their role includes monitoring changes in regulations, developing strategies for approval, and ensuring ongoing compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a regulatory affairs manager, and why are they important?

To thrive as a Regulatory Affairs Manager, you need a comprehensive understanding of regulatory guidelines, scientific or technical expertise, and typically a degree in life sciences or a related field. Experience with submission management systems, regulatory databases, and knowledge of global regulatory frameworks (such as FDA, EMA, or ICH) are highly valuable. Strong attention to detail, communication skills, and the ability to manage cross-functional teams distinguish top performers in this role. These competencies are crucial for ensuring product compliance, minimizing approval risks, and facilitating smooth market entry.

What are some common challenges faced by regulatory affairs managers when working with cross-functional teams?

Regulatory Affairs Managers often encounter challenges in aligning regulatory requirements with the goals of other departments, such as R&D, marketing, and manufacturing. Navigating differing priorities and timelines can be complex, especially when ensuring compliance without delaying product development. Effective communication and negotiation skills are essential to bridge gaps between teams, clarify regulatory expectations, and facilitate smooth collaboration. By proactively engaging stakeholders and providing regulatory guidance early in projects, Regulatory Affairs Managers can help teams work together more efficiently and avoid costly compliance issues.

What does a regulatory affairs manager do?

As a regulatory affairs manager, your responsibilities entail ensuring that your employer observes all relevant laws and regulations. You can find employment in various sectors, including pharmaceutical, healthcare, and manufacturing industries. Your duties include compiling all necessary paperwork, evidence, and documentation to report to regulatory authorities. In addition to the management of paperwork and legal requirements, you help companies make operational and strategic decisions based on the regulations they are obligated to follow. You sometimes perform or coordinate audits to ensure compliance, and, in a large company, you oversee a staff of compliance specialists who handle various regulatory affairs tasks.

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

AspectRegulatory Affairs ManagerRegulatory Affairs Specialist
CredentialsBachelor's degree, often advanced certifications (e.g., RAC)Bachelor's degree, entry-level certifications
Work EnvironmentOversees teams, strategic planning, cross-department collaborationExecutes regulatory submissions, document preparation, detailed compliance tasks
Industry UsageUsed in pharmaceutical, biotech, medical device companies for leadership rolesCommonly found in similar industries, focusing on technical regulatory tasks
Search & Comparison IntentUnderstanding managerial responsibilities and scopeFocus on specific regulatory tasks and compliance details

The Regulatory Affairs Manager typically holds a leadership role, overseeing regulatory strategies and teams, while the Regulatory Affairs Specialist handles detailed compliance work and documentation. Both roles require relevant certifications and are essential in regulated industries like pharma and medical devices.

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Regulatory Affairs Manager jobs near you
Infographic showing various Regulatory Affairs Manager job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Regulatory Affairs Manager

THE RITEDOSE CORPORATION

Columbia, SC • On-site

Other

Posted 7 days ago

Job description

The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.

Responsibilities:

  • Provide critical support in writing and editing technical documents to support submissions for internal ANDA projects as well as customer-led global submissions.
  • Serve as primary RA contact on project teams to support product development.
  • Format, publish, and submit documentation to the FDA for initial and lifecycle submissions.
  • Respond to FDA queries and deficiencies.
  • Provide guidance to RA Associates and aid in development of team.
  • Develop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.
  • Monitor and interpret new and evolving regulations and assess impact on company products.
  • Draft, review, and finalize product labeling for ANDA submissions, including structured product labeling.
  • Oversee adverse event reporting process and ensure compliance with reporting requirements.
  • Support due diligence activities, licensing, and partnerships.
  • Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field
  • 5+ years regulatory affairs experience; FDA submission experience required, experience with device and/or drug/device combination products preferred
  • Highly detail-oriented and possess considerable problem-solving and organization skills
  • Ability to work on complex projects and take initiative with general direction and minimal guidance
  • Ability to be flexible with a change in priorities
  • Excellent written, verbal, and listening skills, must work well with others
  • Experience using an electronic document control system
  • Experience with eCTD publishing software preferred
  • Proficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
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About Ritedose

Sourced by ZipRecruiter

Industry

Pharmaceutical and medicine manufacturing

Company size

501 - 1,000 Employees

Headquarters location

Columbia, SC, US

Year founded

1995

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