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$118.5K

How much do regulatory operations manager jobs pay per year?

As of Sep 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 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.

What are the key skills and qualifications needed to thrive as a regulatory operations manager?

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.

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 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.

Is regulatory compliance a stressful job?

Regulatory Operations Managers often find regulatory compliance to be demanding due to strict deadlines, detailed documentation, and the need to stay current with evolving regulations. The role requires strong attention to detail, organizational skills, and the ability to manage multiple priorities, which can contribute to work-related stress.

Is regulatory operations a good career path?

Regulatory operations is a viable career path for professionals interested in compliance, documentation, and process management within regulated industries such as pharmaceuticals, biotech, and healthcare. It often requires strong attention to detail, knowledge of regulatory requirements, and proficiency with tools like document management systems. The role offers opportunities for advancement and specialization, with demand driven by industry regulations and compliance needs.
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Regulatory Operations Manager jobs near you
Infographic showing various Regulatory Operations Manager job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 79% Full Time, 17% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $63,456 per year, or $30.5 per hour.

Sr Manager, Regulatory Operations - Publishing & Registration Management (Devices)

Fort Worth, TX • On-site

Alcon Laboratories Holding Corporation
See more jobs at Alcon Laboratories Holding Corporationexternal

Full-time

Medical, Life, Retirement, PTO

Posted 14 days ago

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Manager, Regulatory Operations (Management Path) is primarily responsible for directing product/process submissions, ensuring timely approvals, and maintaining high-quality regulatory support. You will lead negotiations to align on optimized regulatory strategies and manage global strategies to enhance product value.

In this role, a typical day will include:

  • Oversee multiple regulatory operations projects, ensuring goals are met through effective management and oversight in support of medical device and/or pharmaceutical products
  • Lead teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling, ensuring timely and accurate submission of regulatory documents
  • Make key decisions impacting project performance and success
  • Apply project management, advanced problem-solving, effective communication, leadership, and industry-specific knowledge
  • Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and ensuring quality control
  • Commit to continuous improvement and compliance with regulatory requirements

WHAT YOU'LL BRING TO ALCON:

  • Bachelor's Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
  • The ability to fluently read, write, understand and communicate in English
  • 7 Years of Relevant Experience
  • 5 Years of Demonstrated Leadership
  • Location: Onsite- Fort Worth, TX, Lake Forest, CA
  • Schedule: 1st Shift: Monday - Friday
  • Travel Requirements: 0-10%
  • Sponsorship & Relocation: Not Available

Preferred Qualifications/Skills/Experience:

  • Demonstrate deep expertise in the regulatory submission lifecycle and associated processes for Class I, Class II, and Class III medical devices across the United States, European Union, and Canada
  • Possess comprehensive knowledge of key regulatory submission platforms and portals, including the U.S. Food and Drug Administration (FDA) electronic Submission Template and Resource (eSTAR), Health Canada Regulatory Enrolment Process (REP), and European Union Notified Body submission portals.
  • Experienced in managing export certification activities through the Center for Devices and Radiological Health (CDRH) Export Certification Application and Tracking System (CECATS), including Certificates to Foreign Government (CFG), Certificates of Exportability (COE), and European Union Free Sale Certificates (FSC).
  • Lead the optimization and standardization of apostille, notarization, legalization, and country-specific documentation processes to support international regulatory submissions, accelerate approval timelines, and improve operational efficiency.
  • Serve as a subject matter expert on global registration and submission pathways, providing strategic guidance for regulatory submissions and market access activities across the U.S., EU, Canada, and international markets.
  • Identify and implement process improvements that reduce submission cycle times, enhance compliance, and improve the quality and consistency of regulatory documentation.

HOW YOU CAN THRIVE AT ALCON:

  • Collaborate with teammates to share standard processes and learnings as work evolves!
  • See your career like never before with focused growth and development opportunities
  • Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
  • Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

Alcon Careers

See your impact atalcon.com.careers

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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Compensation and Benefits

Alcon's Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver longterm value. Our compensation approach includes a combination of fixed and variable pay, with shortterm and longterm incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and wellbeing, provide financial security, and support retirement planning.

The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.

Pay Range

152,150.00 - 196,900.00

Pay Frequency

Annual

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

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