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Biotech Regulatory Affairs Jobs (NOW HIRING)

Legend Biotech US

Director, Regulatory Affairs

Somerset, NJ · Hybrid

$158K - $209K/yr

Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview The Director of Regulatory Affairs is responsible for ...

PrideStaff

Regulatory Affairs Associate

Tustin, CA · On-site

$32 - $36/hr

Regulatory Affairs Associate for a biotechnology company located in Tustin. Temporary to Hire opportunity. Paying $32-36/hr, depending on qualifications. Hours are 9:00 AM - 5:00 PM, Monday-Friday.

Jobtailor

Manager, Regulatory Affairs

Madison, WI · On-site

$150 - $200/hr

Significant regulatory affairs experience within food ingredients, biotechnology, dairy, enzymes, cultures, or another regulated industry * Strong knowledge of United States and/or Canadian ...

New

Kite Pharma

Manager, Regulatory Affairs

... biotechnology functions OR * Master's Degree AND 4+ years of experience in Regulatory Affairs, Promotional Review Operations, Commercial Operations, Medical Affairs Operations, Regulatory Business ...

Gilead Sciences, Inc.

Manager, Regulatory Affairs

... biotechnology functions OR * Master's Degree AND 4+ years of experience in Regulatory Affairs, Promotional Review Operations, Commercial Operations, Medical Affairs Operations, Regulatory Business ...

edrone

NY · On-site

$80 - $100/hr

University degree in Pharmacy, Chemistry, Biochemistry, Medicine, Biotechnology, or a related field* Minimum 3 years of experience in Regulatory Affairs or drug registration* Familiarity with EU ...

YO AI Labs

Regulatory Affairs Expert - Remote

Dallas, TX · Remote

$50 - $80/hr

Required Qualifications * 5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry. * Experience with clinical submissions , regulatory documentation, and health ...

YO AI Labs

Regulatory Affairs Expert - Remote

Chicago, IL · Remote

$50 - $80/hr

Required Qualifications * 5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry. * Experience with clinical submissions , regulatory documentation, and health ...

YO AI Labs

Regulatory Affairs Expert - Remote

Phoenix, AZ · Remote

$50 - $80/hr

Required Qualifications * 5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry. * Experience with clinical submissions , regulatory documentation, and health ...

YO AI Labs

Regulatory Affairs Expert - Remote

Boston, MA · Remote

$50 - $80/hr

Required Qualifications * 5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry. * Experience with clinical submissions , regulatory documentation, and health ...

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Biotech Regulatory Affairs information

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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.
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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.

Sr Manager/Assoc Director, CMC Regulatory Affairs

Erasca

San Diego, CA • On-site, Remote

$175K - $205K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 26 days ago

Job description

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer.
Position Summary:
Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials, as well as planning for future MAA/NDA/BLA(s). This role requires an independent, self-directed, and highly motivated regulatory professional.
Position Responsibilities:
  • Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
  • Prepare and/or review CMC regulatory documents and submissions to support product development (e.g. ND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA) Provide oversight of regulatory submission content and planning, to assure technical accuracy, compliance, and completeness.
  • Assess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies.
  • Collaborate cross-functionally on the eTMF processes and compliance alignment.
  • Represent regulatory on study and program teams throughout study conduct and product development.
  • Support or lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required.
  • Review relevant clinical and CMC documents (protocol, informed consent form, investigator's brochure, and site quality documentation, and required regulatory forms) for regulatory compliance and consistency across submission components.
  • Maintain current knowledge of US and international CMC regulation requirements that apply to company products and processes.
  • Support or lead development of internal Erasca SOPs and processes, as needed.
  • May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs project lead.
  • Perform all duties in keeping with the Company's core values, policies, and all applicable regulations.

Position Requirements:
  • Undergraduate degree required; advanced degree preferred.
  • 5+ years of experience in pharmaceutical or biotech regulatory affairs or related areas, including regulatory affairs for oncology products.
  • Ability to translate regulatory requirements into practical workable plans.
  • Diverse experience with regulatory activities including creation of systems and processes to support efficient and high quality submission of documents to regulatory bodies.
  • Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.
  • Ability to build strong relationships with co-workers of various backgrounds and expertise.
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
  • Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
  • Strong learning orientation, curiosity, and commitment to science and patients.

The anticipated salary range for this position is $175,000 to $205,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.
Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program.
Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.
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About Erasca

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Diego, CA, US

Year founded

2018

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