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Regulatory Documentation Manager Jobs in Raleigh, NC

JobRx, Inc.

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

Oversee document publishing and management of publishing vendor for regulatory submissions ... Responsible for supporting the creation and management of submission plans and ensure coordination ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Oversee document publishing and management of publishing vendor for regulatory submissions ... Responsible for supporting the creation and management of submission plans and ensure coordination ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Oversee document publishing and management of publishing vendor for regulatory submissions ... Responsible for supporting the creation and management of submission plans and ensure coordination ...

Parexel

Senior Clinical Research Associate

Raleigh, NC · On-site

... regulatory documents, and updated or amended regulatory documentation. Customize, review, and ... Clinical Trial Management System (CTMS) and Electronic Document Management System (EDMS); Site ...

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All JobsRegulatory Documentation JobsRegulatory Documentation Manager JobsRegulatory Documentation Manager Jobs in Raleigh, NC

Regulatory Documentation Manager information

See Raleigh, NC salary details

$53K

$107.6K

$176.9K

How much do regulatory documentation manager jobs pay per year?

As of Aug 22, 2026, the average yearly pay for regulatory documentation manager in Raleigh, NC is $107,641.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,300.00 and $132,700.00 per year, depending on experience, location, and employer.

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

AspectRegulatory Documentation ManagerRegulatory Affairs Specialist
Primary FocusManaging and overseeing regulatory documentation processesEnsuring compliance and preparing regulatory submissions
Required CredentialsTypically a degree in life sciences or related field, with experience in documentationSimilar credentials, often with additional certification in regulatory affairs
Work EnvironmentRegulatory or compliance departments within pharmaceutical or medical device companiesRegulatory departments, often collaborating across teams
Industry UsageCommonly used in regulated industries like pharma and medical devicesWidely used in the same industries, often with overlapping responsibilities

While both roles operate within regulated industries and require knowledge of compliance standards, the Regulatory Documentation Manager primarily oversees the management of regulatory documents, whereas the Regulatory Affairs Specialist focuses on ensuring overall regulatory compliance and preparing submissions. Understanding these distinctions helps in choosing the right career path or job search focus.

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

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

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

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

What cities near Raleigh, NC are hiring for Regulatory Documentation Manager jobs?

Cities near Raleigh, NC with the most Regulatory Documentation Manager job openings:

Regulatory Documentation Manager jobs near you
Infographic showing various Regulatory Documentation Manager job openings in Raleigh, NC as of June 2026, with employment types broken down into 1% As Needed, 65% Full Time, 32% Part Time, 1% Temporary, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $107,641 per year, or $51.8 per hour.

Senior Manager, Regulatory Affairs

Azurity Pharmaceuticals - US

Raleigh, NC • Hybrid

Full-time

Posted 12 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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