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Internship Biotech Regulatory Affairs Jobs (NOW HIRING)

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI · On-site

The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for ... biotechnology regulations. As the regulatory leader for North America, this position serves as the ...

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI · On-site

The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for ... biotechnology regulations. As the regulatory leader for North America, this position serves as the ...

Oterra

Regulatory Affairs Manager

Mount Pleasant, WI

The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for ... biotechnology regulations. As the regulatory leader for North America, this position serves as the ...

Legend Biotech US

Director, Regulatory Affairs

Somerset, NJ · On-site

$158K - $209K/yr

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Role Overview The Director of Regulatory Affairs is responsible for independently developing ...

Oterra

Regulatory Affairs Manager

Sturtevant, WI · On-site

The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for ... biotechnology regulations. As the regulatory leader for North America, this position serves as the ...

Legend Biotech USA, Inc.

$158K - $209K/yr

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Role OverviewThe Director of Regulatory Affairs is responsible for independently developing ...

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Internship Biotech Regulatory Affairs information

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$15

$34

$145

How much do internship biotech regulatory affairs jobs pay per hour?

As of Sep 8, 2026, the average hourly pay for internship biotech regulatory affairs in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What is an internship biotech regulatory affairs?

Internship Biotech Regulatory Affairs positions are entry-level roles designed for students or recent graduates interested in gaining experience in the regulatory aspects of the biotechnology industry. Interns typically assist regulatory affairs professionals in preparing and submitting documents to regulatory agencies, ensuring compliance with applicable laws and guidelines, and supporting product development teams. These internships provide hands-on exposure to regulatory strategy, documentation, and communication with authorities such as the FDA or EMA. They are an excellent way to learn about the regulatory environment and start building a career in biotech regulatory affairs.

What do internship biotech regulatory affairs interns do?

As a Biotech Regulatory Affairs intern, you can expect to support the preparation and review of regulatory documents, help track regulatory submissions, and assist in maintaining compliance records. Interns often collaborate with cross-functional teams such as research, quality assurance, and clinical departments to gather data and ensure documentation aligns with regulatory standards. This role provides a unique opportunity to learn about regulatory pathways, understand submission processes, and gain hands-on experience with industry regulations—skills that are highly valued in the biotech sector.

What are the key skills and qualifications needed to thrive as an internship biotech regulatory affairs?

To thrive as an intern in Biotech Regulatory Affairs, you need a foundational understanding of life sciences, regulatory guidelines, and strong analytical skills, typically supported by a degree in biology, biotechnology, or a related field. Familiarity with regulatory databases, document management systems, and industry standards such as FDA or EMA guidelines is highly valued. Attention to detail, strong organizational abilities, and effective communication are essential soft skills for collaborating with cross-functional teams and ensuring compliance. These competencies are crucial to help ensure that biotech products meet regulatory requirements, enabling safe and timely product approvals.

What is the difference between Internship Biotech Regulatory Affairs vs Biotech Regulatory Affairs Specialist?

AspectInternship Biotech Regulatory AffairsBiotech Regulatory Affairs Specialist
CredentialsEnrolled in or recent graduate of life sciences or related fieldBachelor's or master's in life sciences, with relevant certifications
Work EnvironmentInternship setting, learning-focused, supervisedFull-time professional role, independent responsibilities
Employer & IndustryBiotech companies, contract research organizations, regulatory consulting firmsBiotech and pharmaceutical companies, regulatory agencies

Internship Biotech Regulatory Affairs positions are entry-level, designed for students or recent graduates gaining industry experience. In contrast, Biotech Regulatory Affairs Specialists are full-time professionals responsible for preparing regulatory submissions and ensuring compliance. The internship offers foundational exposure, while the specialist role involves independent decision-making and advanced knowledge.

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Internship Biotech Regulatory Affairs jobs near you
Infographic showing various Internship Biotech Regulatory Affairs job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 2% As Needed, 86% Full Time, 9% Part Time, and 2% Contract. Highlights an 85% Physical, 3% Hybrid, and 12% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Senior Director, Regulatory Strategy

Scorpion Therapeutics

Washington, DC • On-site

$150 - $200/hr

Other

Posted 9 days ago

Job description

Key Duties & Responsibilities
  • Lead development of regulatory strategy for multiple/complex development projects (first-in-human to post-marketing), including regulatory submission documents and Health Authority communications.
  • Represent Global Regulatory Affairs (GRA) on core/project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
  • Address complex regulatory issues; provide guidance to cross-functional teams; counsel senior management on global Regulatory Affairs strategies, tactics, procedures, and practices.
  • Develop and manage project plans/timelines; assign/manage resources to prioritize work and meet goals on time.
  • Influence regulatory environment via conferences, industry/agency regulatory meetings, committees, and trade associations; stay current on regulations, policy, intelligence, and competitive issues.
  • Lead continuous improvement of department processes/strategies.
  • Lead GRA functional team(s); coach, develop, and provide performance feedback.
  • People management may include financial and HR responsibilities for assigned staff.
Required Knowledge & Skills
  • Business-minded strategic leader; innovative solutions to regulatory problems.
  • Excellent communication skills; ability to influence decisions; present and document regulatory strategy.
  • Regulatory leadership in cross-functional, matrix environments.
  • Deep expertise in regulatory affairs science and global/regional/local frameworks for human pharmaceutical development (research & development, preclinical/clinical, registration, maintenance).
  • Advanced data/protocol/safety reporting/labeling interpretation across drug development phases.
  • Expertise in proposing regulatory paths and clinical plans; lead productive Health Authority interactions.
  • Ability to assess regulatory pathway adequacy and guide refinements based on regulatory outcomes.
  • Ability to align with strategic vision/core values; improve internal regulatory policies/programs.
  • Cultural sensitivity; embraces diversity; mentors and develops staff.
Required Education & Experience
  • Bachelor's degree in Biology, Chemistry, or related discipline.
  • Typically 12 years' relevant pharmaceutical/biotech regulatory affairs experience and 5 years' supervisory/management experience (or equivalent).
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