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Fda Regulatory Jobs in Raleigh, NC (NOW HIRING)

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Serves as the primary contact for all interactions with regulatory agencies such as the FDA. Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory ...

Osv_bioventus

Regulatory Affairs Manager

Durham, NC · On-site

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Osv_bioventus

Regulatory Affairs Manager

Durham, NC · On-site

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Duke University

Regulatory Coordinator

Durham, NC

$61K - $101K/yr

Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance Other Requirements: * Ability to maintain required certifications and training for clinical research ...

Duke University

Regulatory Coordinator

Durham, NC · On-site

$61K - $101K/yr

Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance Other Requirements: * Ability to maintain required certifications and training for clinical research ...

GSK

Regulatory Compliance Lead

Zebulon, NC · On-site

FDA ). * Coordinates efforts with GSK Regulatory Affairs, LOCs and other business departments to assure all mandatory licenses and registrations are kept current and in compliance with relevant ...

GlaxoSmithKline

Regulatory Compliance Lead

Zebulon, NC · On-site

FDA ). * Coordinates efforts with GSK Regulatory Affairs,LOCsand other business departments toassureall mandatory licenses and registrations are kept current and in compliance with relevant health ...

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How much do fda regulatory jobs pay per hour?

As of Aug 27, 2026, the average hourly pay for fda regulatory in Raleigh, NC is $38.47, according to ZipRecruiter salary data. Most workers in this role earn between $30.87 and $45.58 per hour, depending on experience, location, and employer.

What is an FDA Regulatory?

An FDA Regulatory job involves ensuring that products such as pharmaceuticals, medical devices, and biologics comply with U.S. Food and Drug Administration (FDA) regulations. Professionals in this field prepare and submit regulatory documents, monitor compliance with changing laws, and help companies navigate the approval process. They work closely with internal teams and regulatory agencies to ensure safety, efficacy, and legal adherence.

What are the main responsibilities of an FDA Regulatory?

Professionals in FDA Regulatory roles are primarily responsible for preparing, reviewing, and submitting documents to the FDA to support the approval of pharmaceuticals, medical devices, or other regulated products. You will monitor regulatory changes, ensure company practices comply with relevant laws, and serve as a liaison between your organization and the FDA. Daily tasks often involve cross-functional collaboration with research, quality assurance, and product development teams. This role is both fast-paced and detail-oriented, requiring you to manage multiple projects and adapt to evolving regulatory landscapes.

What are the key skills and qualifications needed to thrive in an FDA Regulatory position?

To thrive in an FDA Regulatory role, you must have a thorough understanding of FDA regulations, submission requirements, and scientific or technical documentation, usually supported by a degree in life sciences or a related field. Proficiency with regulatory submission software (such as eCTD), knowledge of guidance documents, and sometimes RAC certification are highly valued. Strong organizational abilities, problem-solving skills, and clear communication are essential soft skills for coordinating between internal teams and external agencies. These qualifications are vital to ensure compliance, successful product approvals, and effective interaction with regulatory authorities.

How can I get into FDA regulatory?

To enter FDA regulatory roles, candidates typically need a background in life sciences, healthcare, or engineering, along with knowledge of FDA regulations and compliance processes. Relevant experience can be gained through internships, certifications such as RAC (Regulatory Affairs Certification), or working in quality assurance or compliance departments. Strong analytical skills, attention to detail, and understanding of medical device or pharmaceutical development are also important.

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Fda Regulatory jobs near you
Infographic showing various Fda Regulatory job openings in Raleigh, NC as of August 2026, with employment types broken down into 2% As Needed, 85% Full Time, 10% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $80,004 per year, or $38.5 per hour.

Director, Regulatory Affairs

Durham, NC

Pelthos Therapeutics
See more jobs at Pelthos Therapeuticsexternal

$135K - $179K/yr

Full-time

Re-posted 15 days ago

Job description

Job Title:Director, Regulatory Affairs

Department: Pharmaceutical Development


About Pelthos:

Pelthos Therapeutics is a bio-pharmaceutical company committed to commercializing innovative, safe and efficacious therapeutic products to help patients with unmet treatment burdens. For more information, please visit our website at www.pelthos.com or follow usonLinkedInandX.


Job Summary:

The Director, Regulatory Affairs develops, implements, leads and supports regulatory strategies for assigned projects in collaboration with various cross-functional teams. The Director, Regulatory Affairs will execute developed strategies for earliest possible approvals of the company's regulatory applications at all stages of product development and post approval activities. They will facilitate publishing activities with internal and external stakeholders including authoring cover letters forms, eCTD sections and preparing documents for submission to regulatory agencies, as well as ensuring that they meet current regulatory requirements and industry standards, are high quality, consistent, and complete.

Essential Duties & Responsibilities:

Content Management

  • Responsible for content management and integration of content assembled from cross-functional subject matter experts to support document finalization and publishing.

Project Management

  • Ability to develop and execute regulatory strategies for drug development, registration, and post-marketing activities.
  • Assist with the planning, coordination and management of internal regulatory preparatory meetings and the preparation of staff members participating in these meetings that will support formal regulatory interactions.
  • Leads the Regulatory Affairs functional responsibilities in Change Management Activities.
  • Assures regulatory compliance with safety reporting, IND/NDA updates and accessibility to historic documentation required to maintain compliant activities across the organization.
  • Serves as the primary contact for all interactions with regulatory agencies such as the FDA.

Regulatory Submissions

  • Oversee document publishing and management of publishing vendor for regulatory submissions.
  • Responsible for supporting the creation and management of submission plans and ensure coordination of development/commercial activities with the submission processes to drive agreed-upon timelines.

Process Improvement

  • Identify process improvement for internal systems and processes related to publications, submissions and archiving of regulatory records.

Other

  • Monitor and assess changes in regulatory requirements, guidelines, and legislation, and provide guidance to internal stakeholders on potential implications and opportunities for the business.
  • Complete other duties as assigned

Experience & Qualifications:

  • MS or advanced level degree in either chemistry, biological or biomedical related fields.
  • 10+ years demonstrated experience in drug regulatory affairs in the pharmaceutical or biotech industry.
  • In depth knowledge of FDA regulatory requirements with hands on experience interacting directly with the Food and Drug Administration.
  • Experience with the Dermatology and Dental Product Division and/or the Division of Anti-Infectives of the FDA and other regulatory regions and agencies would be an asset including understanding of other medicinal products such as medical device requirements.
  • Ability to think strategically, operationally and tactically to bring regulatory insight to pre-approval and post-approval activities.
  • Experience in guiding an organization around filing strategies.
  • Demonstrated background in coordinating across disciplines to ensure timely filings.
  • Hands-on experience with INDs, and NDAs filing requirements.
  • Ability to work collaboratively as the regulatory affairs business partner to local development and commercialization teams.
  • Sound judgement and ability to analyze situations and information. Makes decisions based on facts and figures rather than on assumptions.
  • Ability to develop an in-depth understanding of milestones and associated implementation timelines for regulatory interactions, strategies, and key decisions points to support existing and future development activities.
  • Strong organization and planning skills.


Physical & Environmental Requirements:

The essential functions of this position include:

  • Lift up to 25lbs on an occasional basis
  • Stand, walk and sit on a frequent basis
  • Stoop, kneel, crouch or crawl on an occasional basis
  • Reach, hands and arms on an occasional basis
  • Use hands to feel on an occasional basis
  • Communicate using hearing and speech on a frequent basis (in-person and/or virtual)
  • Use sense of smell and vision (color difference, depth perception) on an occasional basis
  • Up to 10% of travel (more if not local to Durham, NC office)

These functions must be performed safely and effectively, without posing a direct threat to the employee or others, with or without reasonable accommodation.

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