ZipRecruiter

Log In

1

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 ...

next page

Showing results 1-20

All JobsBiotech Regulatory Affairs Jobs

Biotech Regulatory Affairs information

See salary details

$18

$39

$62

How much do biotech regulatory affairs jobs pay per hour?

As of Sep 7, 2026, the average hourly pay for biotech regulatory affairs in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What is a biotech regulatory affairs?

A Biotech Regulatory Affairs job involves ensuring that biotechnology products comply with regulations set by government agencies, such as the FDA, EMA, or other regulatory bodies. Professionals in this field prepare and submit regulatory documents, monitor compliance, and work with cross-functional teams to address regulatory requirements. They help secure product approvals, maintain regulatory filings, and stay updated on changing laws. This role is essential for bringing safe and effective biotech products to market while meeting legal and quality standards.

What are the key skills and qualifications needed to thrive in biotech regulatory affairs?

To thrive as a Biotech Regulatory Affairs professional, you need a deep understanding of biotechnology regulations, quality systems, and scientific principles, usually supported by a degree in life sciences or a related field. Familiarity with regulatory submission processes, document management systems, and knowledge of international standards (such as FDA, EMA, or ICH guidelines) is crucial, and certifications like RAC (Regulatory Affairs Certification) are highly valued. Strong attention to detail, problem-solving ability, and excellent written and verbal communication make candidates stand out in this role. These skills are essential to ensure products meet regulatory requirements, facilitate approvals, and support successful market entry for biotech innovations.

What are some typical challenges faced in a biotech regulatory affairs role?

Professionals in Biotech Regulatory Affairs often encounter challenges such as navigating complex and evolving international regulations, managing tight submission deadlines, and interpreting new guidance documents. Additionally, balancing the needs of cross-functional teams—like R&D, clinical, and quality assurance—while ensuring compliance can be demanding. Staying current with changes in legislation and regulatory expectations is also essential for ongoing success. Despite these challenges, the role offers great opportunities for professional growth as you influence product development and approval strategies within the biotechnology sector.

Is biotech regulatory affairs high paying?

Biotech regulatory affairs professionals often earn competitive salaries, especially with experience, advanced degrees, and certifications such as RAC. Salaries can vary based on location, company size, and specific responsibilities, but the role generally offers above-average compensation within the biotech industry.
More about Biotech Regulatory Affairs jobs

What cities are hiring for Biotech Regulatory Affairs jobs?

Cities with the most Biotech Regulatory Affairs job openings:

What are the most commonly searched types of Biotech Regulatory Affairs jobs?

The most popular types of Biotech Regulatory Affairs jobs are:

What states have the most Biotech Regulatory Affairs jobs?

States with the most job openings for Biotech Regulatory Affairs jobs include:

What job categories do people searching Biotech Regulatory Affairs jobs look for?

The top searched job categories for Biotech Regulatory Affairs jobs are:

Biotech Regulatory Affairs jobs near you
Infographic showing various Biotech 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 $82,307 per year, or $39.6 per hour.

Senior Director, Regulatory Strategy

Scorpion Therapeutics

Washington, DC • On-site

$150 - $200/hr

Other

Posted 8 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).
#J-18808-Ljbffr

Apply