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Regulatory Operations Manager Jobs (NOW HIRING)

Ardelyx

Regulatory Systems Manager

Newark, CA · On-site

$117K - $143K/yr

The Regulatory Systems Manager is responsible for the administration, optimization, and day-to-day management of regulatory systems that support global regulatory operations. This role will ensure ...

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Regulatory Operations Manager information

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$31K

$63.5K

$118.5K

How much do regulatory operations manager jobs pay per year?

As of Jul 12, 2026, the average yearly pay for regulatory operations manager in the United States is $63,456.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,000.00 and $77,500.00 per year, depending on experience, location, and employer.

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

AspectRegulatory Operations ManagerRegulatory Affairs Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, regulatory affairs, or related field; certifications like RAC are commonSimilar credentials; often holds a bachelor’s degree and may pursue regulatory certifications
Work EnvironmentManages regulatory processes, documentation, and compliance within organizations, often overseeing teamsFocuses on preparing and submitting regulatory documents, ensuring compliance with regulations
Industry UsageUsed across pharmaceutical, biotech, and medical device companies for operational oversightCommonly found in similar industries, focusing on regulatory submissions and communication with authorities

The Regulatory Operations Manager oversees the regulatory process, managing teams and ensuring compliance, while the Regulatory Affairs Specialist concentrates on preparing submissions and liaising with regulatory agencies. Both roles require similar credentials and are vital in regulated industries, but their focus areas differ slightly.

How does a Regulatory Operations Manager collaborate with cross-functional teams to ensure timely regulatory submissions?

A Regulatory Operations Manager works closely with regulatory affairs, clinical, quality assurance, and project management teams to coordinate the preparation, review, and submission of regulatory documents. They serve as a central point of contact, facilitating communication and aligning timelines to ensure all required materials are gathered and compliant with regulatory standards. By organizing regular meetings and utilizing document management systems, they help streamline the submission process and proactively identify and resolve potential bottlenecks.

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

To thrive as a Regulatory Operations Manager, you need expertise in regulatory compliance, project management, and a relevant degree in life sciences or a related field. Familiarity with electronic document management systems (EDMS), regulatory submission platforms like eCTD, and knowledge of global regulatory requirements are typically required. Strong attention to detail, organizational skills, and effective cross-functional communication set outstanding professionals apart in this role. These competencies are crucial for ensuring timely, accurate regulatory submissions and facilitating seamless collaboration within regulatory and cross-functional teams.

What does a Regulatory Operations Manager do?

A Regulatory Operations Manager oversees the processes and systems required to ensure an organization complies with all regulatory requirements, especially in highly regulated industries like pharmaceuticals, finance, or healthcare. Their responsibilities often include managing the submission of documents to regulatory agencies, ensuring accurate record-keeping, developing compliance strategies, and coordinating with various internal departments. They play a critical role in maintaining regulatory standards and facilitating timely approvals for product launches or business activities.
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Regulatory Operations Manager jobs near you
Regulatory Operations Documentation Specialist

Regulatory Operations Documentation Specialist

Shionogi Inc.

Florham Park, NJ

$40 - $57/hr

Full-time

Posted 24 days ago

Job description

This role will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission.  The scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. The role also involves archiving correspondence with Health Authorities, as well as managing documents stored at or retrieved from offsite facilities. The ideal candidate will bring experience with Microsoft Word, Adobe Acrobat, and Veeva RIM.


Below is a list of the main activities needed to fulfill the requirements of the role. It is not meant to be a comprehensive list, but rather, provide an overview of the specialized skills and expertise required:

  • Support document formatting and QC in alignment with Shionogi standards for submission-related materials.
  • Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
  • Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
  • Assist the archiving and retrieval of documents from offsite storage facilities.
  • Provide ongoing support to the Regulatory Operations team.

Minimum Job Requirements

  • High school degree required; Associate’s degree preferred.
  • Pharmaceutical industry experience is a plus, but not required.
  • Proficient in MS Office and Acrobat Adobe.
  • Experience with ISI Toolbox or equivalent software packages.
  • Experience with database systems; Veeva is a plus.
  • High level of attention to detail and accuracy in work.
  • Effective time management and organizational skills.
  • Strong written and verbal communication skills.
  • Able to work within a high-performance, collaborative team environment.

Additional Information

The hourly rate for this position is $40 - $57. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, applicable allowances, or any additional compensation that may be associated with this role. 


Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.

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About Shionogi

Sourced by ZipRecruiter

Industry

Pharmaceutical and medicine manufacturing

Company size

201 - 500 Employees

Headquarters location

Florham Park, NJ, US

Year founded

2001

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