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Regulatory Affairs Manager Engineer Jobs (NOW HIRING)

NY · On-site

$60 - $80/hr

Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality ... Certification in regulatory affairs, quality management, compliance, auditing preferred. #J-18808 ...

NY · On-site

$80 - $100/hr

Regulatory Affairs Manager - Poland** to support regulatory strategy, submissions, lifecycle ... Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality ...

Regulatory Affairs Manager

Santa Clara, CA · On-site

$120K - $145K/yr

Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...

Regulatory Affairs Manager

Santa Clara, CA · On-site

$120K - $145K/yr

Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...

Regulatory Affairs Manager

Santa Clara, CA · On-site

$120K - $145K/yr

Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...

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 ...

Regulatory Affairs Manager

Sarasota, FL · On-site

$100 - $125/hr

Education Bachelor's degree in Quality, Regulatory Affairs or an applicable science (Engineering ... Risk management (ISO 14971). Clinical evaluation requirements. Change control and post-market ...

New

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 ...

WI · On-site

$80 - $100/hr

We are looking for a Regulatory Affairs Manager who is experienced, hands‑on, and communicative to join us in our Regulatory Affairs team, based in our EMEA headquarters office in Mechelen, Belgium.

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 ...

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 ...

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

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Regulatory Affairs Manager Engineer information

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$56

$86

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

As of Sep 8, 2026, the average hourly pay for regulatory affairs manager engineer 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.

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For Regulatory Affairs Manager Engineer jobs, the most frequently searched job titles are:

Infographic showing various Regulatory Affairs Manager Engineer job openings in the United States as of June 2026, with employment types broken down into 53% Full Time, 41% Part Time, 3% Temporary, and 3% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Full-time

Re-posted 10 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