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Regulatory Operations Jobs in Raleigh, NC (NOW HIRING)

MMS

Senior Nonclinical Writer (US)

Raleigh, NC · On-site

Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC. * Demonstrated ability to lead others to complete complex projects.

NC SECU

Regulatory Compliance Analyst

Raleigh, NC · Hybrid

Loan Administration, Deposits & Operations, Card Services and Human Resources) to determine compliance with applicable regulatory requirements and identify regulatory gaps which present risk to the ...

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How much do regulatory operations jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for regulatory operations in Raleigh, NC is $25.51, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $29.42 per hour, depending on experience, location, and employer.

What is a regulatory operations job?

A Regulatory Operations job involves managing the submission and compliance processes required for regulatory approval of products, typically in industries like pharmaceuticals, biotechnology, and medical devices. Responsibilities include formatting and submitting regulatory documents, ensuring compliance with global regulations, and maintaining submission lifecycle management. This role often requires collaboration with cross-functional teams, expertise in regulatory guidelines, and proficiency in regulatory submission systems such as eCTD.

What are common day-to-day responsibilities for professionals in regulatory operations?

Regulatory Operations professionals are primarily responsible for preparing, formatting, and submitting regulatory documents to health authorities, ensuring they meet stringent compliance standards. They coordinate with cross-functional teams—such as clinical, quality, and legal departments—to gather and verify required information. Daily tasks often include managing document workflows, maintaining regulatory databases, and tracking submission timelines. This role requires close attention to regulatory updates and an ability to quickly adapt processes in response to changing requirements.

What are the key skills and qualifications needed to thrive in regulatory operations, and why are they important?

To excel in Regulatory Operations, candidates should have a strong understanding of regulatory guidelines, documentation processes, and compliance standards—often supported by a degree in life sciences, pharmacy, or a related field. Familiarity with electronic document management systems (EDMS), submission publishing tools, and possibly certifications such as Regulatory Affairs Certification (RAC) are commonly expected. Excellent attention to detail, project management, and effective communication skills enable individuals to coordinate across teams and ensure timely submissions. These competencies are critical for maintaining compliance, minimizing risk, and supporting the efficient approval of products in highly regulated industries.

What are the most commonly searched types of Regulatory Operations jobs in Raleigh, NC?

The most popular types of Regulatory Operations jobs in Raleigh, NC are:

What are popular job titles related to Regulatory Operations jobs in Raleigh, NC?

For Regulatory Operations jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Regulatory Operations jobs in Raleigh, NC look for?

The top searched job categories for Regulatory Operations jobs in Raleigh, NC are:

Regulatory Operations jobs near you
Infographic showing various Regulatory Operations job openings in Raleigh, NC as of August 2026, with employment types broken down into 83% Full Time, 14% 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 $53,061 per year, or $25.5 per hour.

Senior Manager, Regulatory Affairs

Azurity Pharmaceuticals - US

Raleigh, NC • Hybrid

Full-time

Posted 26 days ago

Job description

Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects.  Project may support developmental product activities as well as the life-cycle management of commercial products. Responsibilities include providing regulatory guidance, determining requirements and strategy for assigned projects, authoring Health Authority (HA) submissions for US and for Canada, and ensuring compliance with regulations, company standards and commitments.

 Principle Responsibilities:

  • Represent Regulatory Affairs on assigned product and related project teams (both internal and external cross-functional teams)
  • Provide regulatory assessment of due diligence requests to support new business development activities.
  • Serve as primary interface with FDA and Health Canada for assigned products. Prepare and author portions of Health Authority meeting request and briefing documents.  Attend Health Authority meetings as assigned.
  • Drive regulatory strategies for drug product registration and for life-cycle management across North America.
  • Manage regulatory filings including IND, NDA, ANDA, NDS, DMF for a variety of dosage forms including solid oral, parenteral, liquids, topicals, inhalation and nasal, and drug/device combination drug products. Respond to FDA or Health Canada Requests for Information.
  • Manage operational aspects of preparing compliant submissions to regulatory agencies.
  • Establish and manage timelines associated with regulatory submissions.
  • Manage archive of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms as per Azurity SOPs.
  • Provide regulatory guidance on requirements for post-approval/life-cycle changes, as required, for assigned commercial products including change control assessments.
  • Provide regulatory support for Senior Leadership Team (SLT) and Executive Leadership Team (ELT) meetings and presentations.
  • Monitor evolving, region-specific regulations and proactively provide strategic guidance to cross-functional teams to ensure compliance.
  • Assist in preparing budgets and reviewing invoices on assigned projects and relevant product/filing fees, as needed.
  • Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.

Qualifications and Education Requirements

  • Minimum Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
  • Minimum of 10 years in the pharmaceutical industry with at least 8 of those years in regulatory affairs.
  • Combination of education and applicable job experience may be considered.
  • Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
  • Track record of successfully working with cross-functional teams, including external partners
  • Ability to work independently with minimal supervision in a fast-paced deadline driven environment.
  • Keen attention to detail.
  • Ability to rapidly adapt to changing environment and circumstances that require flexibility, tolerance and a great sense of urgency while ensuring that all regulatory requirements are met.
  • Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.

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