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Regulatory Affairs Operations Jobs (NOW HIRING)

Just Energy

Manager Regulatory Affairs

Austin, TX · On-site

The position is primarily focused on Texas retail regulatory affairs, while also providing support on wholesale regulatory matters that affect the company's retail operations and additional ...

Allergan

$120 - $170/hr

The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission ... Experience in Regulatory Operations, including regulatory submission project management and/or ...

New

Just Energy

Manager Regulatory Affairs

Austin, TX · Remote

The position is primarily focused on Texas retail regulatory affairs, while also providing support on wholesale regulatory matters that affect the company's retail operations and additional ...

Oscar Health

Analyst, Regulatory Affairs

Tempe, AZ · On-site

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... Familiarity with health insurance operations * Experience with the individual market health ...

World Courier

NY · On-site

$47.48 - $79.14/hr

Explore our careers.Regulatory Affairs Manager page is loaded## Regulatory Affairs ... Comply with, maintain, and improve internal regulatory and operational processes* Coordinate ...

Verathon, Inc.

Manager, Regulatory Affairs

Bothell, WA · On-site

Translate Regulatory Affairs functional plans into operational processes, contribute to annual regulatory strategy and planning, and advise senior leadership on regulatory risk affecting business ...

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Regulatory Affairs Operations information

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How much do regulatory affairs operations jobs pay per hour?

As of Sep 2, 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 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 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 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.

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.

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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 84% Full Time, 13% Part Time, 1% Temporary, 1% Contract, and 1% Nights. 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.

Regulatory Affairs Manager

Gateway Recruiting

San Jose, CA • On-site

Full-time

Re-posted 24 days ago

Job description

Job Summary

This Regulatory Affairs Manager position is an onsite opportunity. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. This new team member has department/group/site level influence and is generally recognized as an expert resource and mentor within the department.

Job Responsibilities

  • Develop new regulatory policies, processes and SOPs and train key staff on them.
  • Evaluate regulatory risks of division policies, processes, procedures.
  • Provide regulatory input to product lifecycle planning.
  • Provide strategic input and technical guidance on regulatory requirements to development teams.
  • Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives.
  • Assist in the development of multi-country regulatory strategies and update strategy based upon regulatory changes.
  • Support pre and post approval clinical strategy and submission activities.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
  • Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing.
  • Compile, prepare, review and submit regulatory submissions to authorities.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
  • Ensure compliance with US and global product post marketing approval requirements.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Execute and manage technical and scientific regulatory activities.
  • Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met.
  • Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.
  • Properly interpret and apply regulatory requirements.
  • Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
  • Provide leadership and guidance towards achieving department objectives and act as a mentor to less experienced staff.
  • May supervise exempt or non-exempt employees.
  • May lead a cross-functional or cross-divisional project team.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Required Qualifications

  • Bachelor's Degree in a related field OR an equivalent combination of education and work experience
  • Minimum 4 years of experience in a regulated industry (e.g., medical products, nutritionals).
  • 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas. Note: Higher education may compensate for years of experience.
  • Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
  • Domestic and international regulatory guidelines, policies and regulations.
  • Lead functional groups in the development of relevant data to complete a regulatory submission.

Preferred Qualifications

  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
  • Master's or Ph.D. in a technical area.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
  • Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions.
  • Experience with Class II and Class III medical devices.
  • Ability to define regulatory strategy.
  • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
  • Experience with post-approval manufacturing and design changes.
  • Ability to work effectively on cross-functional teams.
  • Strong attention to detail.
  • Experience with organizing and tracking complex information.
  • Able to juggle multiple and competing priorities.
  • Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Has broad knowledge of various technical alternatives and their potential impact on the business.
  • Uses in-depth knowledge of business functions and cross group dependencies/ relationships.