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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 ...

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 ...

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 ...

UCB

GRA Device Lead, Raleigh, NC

Raleigh, NC · Hybrid

$148K - $195K/yr

Experience with CE Mark, Notified Body, and/or FDA regulatory processes. * Strong regulatory strategy, risk assessment, and communication skills. * Ability to influence and collaborate across cross ...

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Fda Regulatory information

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How much do fda regulatory jobs pay per hour?

As of Aug 1, 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 the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, which can have salaries exceeding $200,000 annually. These positions often require extensive experience, advanced degrees, and leadership skills, and may include additional benefits and bonuses.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, which can offer salaries exceeding $150,000 annually. These roles often require extensive experience, advanced certifications, and leadership skills in managing regulatory strategies for large organizations or global markets.

What are the key skills and qualifications needed to thrive in the Fda Regulatory position, and why are they important?

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.

What qualifications do you need to work for the FDA?

To work as an FDA regulatory professional, candidates typically need a bachelor's degree in a relevant field such as life sciences, engineering, or healthcare. Advanced degrees or specialized certifications in regulatory affairs or quality assurance can enhance prospects, and strong knowledge of FDA regulations and good communication skills are essential.

What is an FDA Regulatory job?

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 someone working in an FDA Regulatory position?

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.

Is it hard to get a job at FDA?

Getting a job as an FDA regulatory professional can be competitive due to strict qualification requirements, including relevant education, experience, and sometimes certifications like RAC. The hiring process often involves multiple steps, including exams and interviews, and familiarity with regulatory guidelines is essential.
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Fda Regulatory jobs near you
Infographic showing various Fda Regulatory job openings in Raleigh, NC as of July 2026, with employment types broken down into 84% Full Time, 6% Part Time, 6% Temporary, and 4% Contract. Highlights an 86% In-person, 5% Hybrid, and 9% Remote job distribution, with an average salary of $80,009 per year, or $38.5 per hour.

Director, Regulatory Affairs

Pelthos Therapeutics

Durham, NC • On-site

$135K - $179K/yr

Full-time

Re-posted 20 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 uson LinkedIn and X.
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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