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Regulatory Affairs Operations Jobs (NOW HIRING)

Taiho Oncology

$86K - $102K/yr

The Regulatory Affairs Operations team creates and manages investigational and marketing applications to health authorities like the FDA and EMA, compiles required data and maintains compliance with ...

Uw

Regulatory Affairs Operations Manager

Seattle, WA · On-site

$174K/yr

Harborview Medical Center Quality Assurance has an outstanding opportunity for a Clinical Program Operations Manager of Regulatory Affairs . WORK SCHEDULE 100% FTE 100% Onsite POSITION HIGHLIGHTS ...

Abbott

Regulatory Affairs Specialist

Pleasanton, CA · On-site

The Opportunity This Regulatory Affairs Specialist will work out of our Pleasanton, CA location in ... Regulatory Operations DIVISION: HF Heart Failure LOCATION: United States > Pleasanton : 6101 ...

Abbott

Regulatory Affairs Specialist

Pleasanton, CA · On-site

The Opportunity This Regulatory Affairs Specialist will work out of our Pleasanton, CA location in ... Regulatory Operations DIVISION: HF Heart Failure LOCATION: United States > Pleasanton : 6101 ...

Abbott

Regulatory Affairs Specialist

Pleasanton, CA · On-site

The Opportunity This Regulatory Affairs Specialist will work out of our Pleasanton, CA location in ... Regulatory Operations DIVISION: HF Heart Failure LOCATION: United States > Pleasanton : 6101 ...

Abbott

Regulatory Affairs Specialist

Pleasanton, CA · On-site

Regulatoryarea ispreferred but may consider quality assurance, research and development/support, scientific affairs, operations, or relatedarea. * Regulatory Knowledge of: Regulatory history ...

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How much do regulatory affairs operations jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for regulatory affairs operations 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.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Operations professional?

To thrive in Regulatory Affairs Operations, you need a strong understanding of regulatory guidelines, document management, and compliance procedures, often backed by a degree in life sciences or a related field. Familiarity with regulatory submission platforms, electronic document management systems (EDMS), and certifications such as RAC (Regulatory Affairs Certification) are typically important. Exceptional attention to detail, organizational skills, and effective communication help you excel in managing complex regulatory documentation and stakeholder interactions. These skills are critical to ensure accurate, timely submissions and ongoing compliance with global regulatory requirements.

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

AspectRegulatory Affairs OperationsRegulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences or related field; certifications like RAC are commonSame as Regulatory Affairs Operations, often requiring similar certifications
Work EnvironmentFocuses on process management, documentation, and compliance activities within regulatory teamsInvolves preparing submissions, liaising with authorities, and ensuring product compliance
Employer & Industry UsageUsed across pharmaceutical, biotech, and medical device companies for operational supportCommonly used in similar settings for product-specific regulatory tasks

Regulatory Affairs Operations roles focus on managing regulatory processes and documentation, ensuring smooth compliance workflows. Regulatory Affairs Specialists handle product submissions and communication with regulatory agencies. Both roles require similar credentials and work environments but differ in their primary responsibilities within the regulatory process.

What is Regulatory Affairs Operations?

Regulatory Affairs Operations refers to the processes, systems, and teams that support regulatory affairs activities in industries such as pharmaceuticals, biotechnology, and medical devices. This function focuses on ensuring that regulatory submissions, documentation, and compliance activities are managed efficiently and in accordance with global regulatory requirements. Regulatory Affairs Operations professionals handle document management, submission planning, and electronic regulatory systems, enabling organizations to gain and maintain product approvals. Their work is critical for meeting deadlines, maintaining compliance, and facilitating communication with regulatory agencies.

What are some common challenges faced by professionals in Regulatory Affairs Operations, and how can they be managed?

Professionals in Regulatory Affairs Operations often navigate rapidly changing regulations and tight submission deadlines, which can be challenging. Staying organized and proactive in monitoring regulatory updates is critical. Effective collaboration with cross-functional teams, such as clinical, quality, and legal departments, helps ensure timely and accurate regulatory submissions. Leveraging project management tools and maintaining clear communication channels can also help manage workload and maintain compliance.
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Regulatory Affairs Operations jobs near you
Infographic showing various Regulatory Affairs Operations job openings in the United States as of August 2026, with employment types broken down into 86% Full Time, 11% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Manager I, Regulatory Affairs Operations

Tarsus Pharmaceuticals

Irvine, CA • On-site, Remote

Full-time

Medical, Dental, Vision, PTO

Posted 11 days ago

Job description

About the Role

The Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and regulatory submissions activities.

Let's talk about some of the key responsibilities of the role:

  • Create and Maintain Content Plans within Veeva Vault RIM, understanding of eCTD Hierarchy/Modules and content planning.
  • Assist with planning, managing, archiving of submissions/regulatory authority correspondence, Ad & Promo submissions, dossier lifecycle management. Maintain compliance to regulatory requirements for annual reporting, etc.
  • Support RA submissions team/s with project management activities, tasks and tracking.
  • Assist with coordination and communication of regulatory submissions with external Publishing vendors.
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
  • Assist in Reg Ops team management and help to develop fully functional regulatory operations team, including processes and systems.
  • Excellent organization, written/verbal communication and attention to detail.
  • EDMS & Submission Technology: Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems (proficiency in Veeva RIMS required). In addition, proficiency working with eCTD templates (e.g., eCTD StartingPoint Templates, etc.). Preferred technology: Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox.
  • Project Management Technology: Experience and proficiency with project management tools and software such as Microsoft Word, Project, Excel, etc.
  • Maintenance of individual training records and completion of all designated required training.

Factors for Success:

  • Bachelor's degree in science or health-related discipline or equivalent experience.
  • Minimum of 5+ years of Regulatory Affairs Operations Experience, with a focus on publishing and/or submissions management, records management.
  • In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS
  • Under the guidance of the Director, knowledgeable resource for regulatory advice in developing submission content plans, with hands-on responsibility for regulatory document management.
  • Experience working with Veeva Regulatory Information Management System Vault is required; administrator experience/management of Veeva RIMS is a requirement.
  • Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to RA operational activities.
  • Demonstrated ability to contribute to a continuous learning and process improvement.
  • Strong analytical skills, good attention to detail.
  • Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Ability to work independently as needed with minimal supervision.
  • Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there's not a blueprint for success. Owns their decisions and actions.
  • Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
  • Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met. 

A Few Other Details Worth Mentioning:

  • The position will be based in our beautiful Irvine office, complete with an onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment; remote work may be considered.
  • We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
  • This position reports directly to our Director, Regulatory Affairs Operations.
  • Some travel may be required - up to 20%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $97,500 - $136,500 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

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