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Intern Biomedical Regulatory Affairs Jobs (NOW HIRING)

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

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.

Pelthos Therapeutics Inc.

$150 - $210/hr

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.

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

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.

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

$120 - $170/hr

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...

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How much do intern biomedical regulatory affairs jobs pay per hour?

As of Sep 5, 2026, the average hourly pay for intern biomedical regulatory affairs in the United States is $16.69, according to ZipRecruiter salary data. Most workers in this role earn between $14.42 and $18.75 per hour, depending on experience, location, and employer.

What does an intern in biomedical regulatory affairs do?

An Intern in Biomedical Regulatory Affairs assists with ensuring that biomedical products comply with government regulations and industry standards. This role typically involves supporting the preparation and submission of regulatory documents, researching relevant regulations, and maintaining records for audits. Interns may also help coordinate communication between regulatory agencies and internal teams, learning about the lifecycle of medical devices, pharmaceuticals, or biotechnology products. This experience provides valuable insight into the regulatory environment of the biomedical industry.

What are some typical projects or tasks an intern in biomedical regulatory affairs might work on during their internship?

As an Intern in Biomedical Regulatory Affairs, you can expect to support the preparation and review of regulatory documents, assist with compiling data for submissions to regulatory agencies, and help monitor compliance with relevant laws and guidelines. Interns often participate in cross-functional meetings with teams such as Quality Assurance, Research & Development, and Clinical Affairs to understand the regulatory impact on product development. This hands-on experience provides valuable insight into the regulatory approval process and offers opportunities to develop skills in document management, research, and regulatory strategy.

What are the key skills and qualifications needed to thrive as an intern in biomedical regulatory affairs, and why are they important?

To thrive as an Intern in Biomedical Regulatory Affairs, you need a solid background in life sciences or biomedical engineering, attention to detail, and familiarity with regulatory guidelines such as FDA or EMA requirements. Experience with document management systems, regulatory submission platforms, and knowledge of standards like ISO 13485 is highly beneficial. Strong organizational skills, effective communication, and the ability to collaborate across teams help interns excel in this role. These skills ensure compliance, facilitate the approval process, and support bringing safe medical products to market efficiently.

What is the difference between Intern Biomedical Regulatory Affairs vs Intern Clinical Research Coordinator?

AspectIntern Biomedical Regulatory AffairsIntern Clinical Research Coordinator
Required CredentialsBasic life sciences background, knowledge of regulationsBackground in health sciences, familiarity with clinical protocols
Work EnvironmentRegulatory departments, compliance teamsClinical sites, hospitals, research centers
Employer & Industry UsagePharmaceutical, biotech, medical device companiesHospitals, research institutions, clinical trial sites
Common Search & Comparison IntentUnderstanding regulatory roles, career pathsClinical trial processes, patient coordination

Intern Biomedical Regulatory Affairs focuses on regulatory compliance, documentation, and ensuring products meet legal standards, often within pharmaceutical or biotech companies. Intern Clinical Research Coordinator involves managing clinical trials, patient interactions, and data collection at research sites. Both roles support clinical development but differ in focus and work environment.

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Intern Biomedical Regulatory Affairs jobs near you
Infographic showing various Intern Biomedical Regulatory Affairs job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $34,721 per year, or $16.7 per hour.

Director, Regulatory Affairs

Pelthos Therapeutics

Durham, NC • On-site

$135K - $179K/yr

Full-time

Re-posted 24 days ago

Key responsibilities

  • Develop, implement, and support regulatory strategies for drug development, registration, and post-marketing activities.

  • Oversee content management, including assembling, finalizing, and publishing regulatory documents from cross-functional teams.

  • Manage regulatory submissions by supporting document creation, coordinating submission plans, and ensuring timely regulatory agency interactions.

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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