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Regulatory Affairs Labelling Associate Jobs (NOW HIRING)

Revolution Medicines

Director, Regulatory Affairs Labeling

$153K - $202K/yr

Revolution Medicines is seeking a Director, Regulatory Affairs Labeling, who will drive cross-functional development and execution of global regulatory labeling strategy for pipeline, late stage, and ...

ITW Car Care

Regulatory Affairs Associate

Lakeland, FL · Hybrid

Position Summary The Regulatory Affairs Associate supports the organization's product stewardship ... Create, review, and maintain Safety Data Sheets (SDSs), product labels, and technical documentation.

Revolution Medicines

Director, Regulatory Affairs Labeling

$153K - $202K/yr

Revolution Medicines is seeking a Director, Regulatory Affairs Labeling, who will drive cross-functional development and execution of global regulatory labeling strategy for pipeline, late stage, and ...

Viltis

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Regulatory Affairs Associate - Medical Devices / IVDR

South Portland, ME · On-site

$20 - $23/hr

Regulatory Affairs Associate - Medical Devices / IVDR Location: South Portland, ME Schedule: Monday ... labeling, and continued product approvals. * Participate in regulatory strategy, risk management ...

RXinsider LTD.

Reviews and approves Marketing/Sales literature and labeling. * Establishes and/or owns regulatory affairs processes and acts as subject matter expert during inspections. * Develops and presents ...

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How much do regulatory affairs labelling associate jobs pay per hour?

As of Sep 12, 2026, the average hourly pay for regulatory affairs labelling associate in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

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Infographic showing various Regulatory Affairs Labelling Associate job openings in the United States as of June 2026, with employment types broken down into 8% As Needed, 62% Full Time, 1% Part Time, 10% Temporary, and 19% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Manager

Columbia, SC • On-site

THE RITEDOSE CORPORATION
Pharmaceutical and Medicine Manufacturing • 501 - 1,000 employees
Learn more about THE RITEDOSE CORPORATIONexternal

Full-time

Re-posted 14 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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