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Remote Biotech Regulatory Affairs Jobs (NOW HIRING)

Jade Biosciences

$135K - $150K/yr

About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on ... Position Location This is a remote role; periodic travel to team and company events is required.

Cardinal Health

... biotechnology companies to obtain regulatory approvals. This function applies subject matter ... This is a remote position, and the ideal candidate will be located near or willing to travel to ...

Vaxcyte

Sr. Manager, Regulatory Affairs

San Carlos, CA · On-site +1

$183K - $194K/yr

... or biotech industry, or in a related field, or the equivalent combination of education and ... US - Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or ...

Oscar Health

Analyst, Regulatory Affairs

Atlanta, GA · Remote

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... This is a remote position, open to candidates who reside in: Atlanta, GA. You will be fully remote ...

Oscar Health

Analyst, Regulatory Affairs

Dallas, TX · Remote

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... This is a remote position, open to candidates who reside in: Dallas, TX. You will be fully remote ...

Oscar Health

Analyst, Regulatory Affairs

Dallas, TX · Remote

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... This is a remote position, open to candidates who reside in: Dallas, TX. You will be fully remote ...

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Remote Biotech Regulatory Affairs information

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

As of Jul 31, 2026, the average hourly pay for remote 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 are the key skills and qualifications needed to thrive as a Remote Biotech Regulatory Affairs professional, and why are they important?

To thrive as a Remote Biotech Regulatory Affairs professional, you need a strong background in biological sciences or related fields, regulatory knowledge, and experience with drug or device development, often supported by a relevant degree or advanced certification such as RAC. Familiarity with regulatory submission systems (e.g., eCTD), FDA/EMA guidelines, and document management platforms is essential. Exceptional attention to detail, written communication, and cross-functional collaboration skills set standout professionals apart in this field. These competencies ensure regulatory compliance, smooth product approvals, and effective coordination across global teams in a highly regulated environment.

What is the difference between Remote Biotech Regulatory Affairs vs Remote Biotech Quality Assurance?

AspectRemote Biotech Regulatory AffairsRemote Biotech Quality Assurance
Primary FocusRegulatory compliance, submissions, and interactions with authoritiesProduct quality, standards, and process validation
Required CredentialsLife sciences degree, regulatory certifications (e.g., RAC)Life sciences degree, quality management certifications (e.g., CQE)
Work EnvironmentCollaborates with regulatory agencies, cross-functional teamsWorks with manufacturing, quality control, and validation teams
Industry UsageCommon in biotech, pharma, and medical device companiesPrevalent in biotech, pharma, and manufacturing sectors

Remote Biotech Regulatory Affairs focuses on ensuring products meet regulatory standards and managing agency submissions, while Remote Biotech Quality Assurance emphasizes maintaining product quality and compliance through internal processes. Both roles require similar credentials and often collaborate but serve distinct functions within biotech companies.

What are Remote Biotech Regulatory Affairs professionals?

Remote Biotech Regulatory Affairs professionals are specialists who ensure that biotechnology products and processes comply with all relevant regulations and laws. Working remotely, they manage documentation, submissions, and communications with regulatory agencies to facilitate product approvals. They play a key role in keeping companies compliant with evolving guidelines, such as those from the FDA or EMA, while working from locations outside traditional offices. Their work ensures that new biotech products are safe, effective, and legally marketable.

How does a Remote Biotech Regulatory Affairs professional typically collaborate with cross-functional teams while working offsite?

In a remote Biotech Regulatory Affairs role, professionals frequently interact with teams such as research, clinical, quality assurance, and legal through virtual meetings and collaborative platforms. Regular communication is essential to coordinate submission timelines, ensure documentation accuracy, and address regulatory concerns promptly. Successful remote professionals are adept at using project management tools and maintaining proactive communication to bridge any gaps caused by physical distance. This collaborative approach helps ensure that regulatory requirements are met efficiently and that projects progress smoothly.
More about Remote Biotech Regulatory Affairs jobs
What cities are hiring for Remote Biotech Regulatory Affairs jobs? Cities with the most Remote 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:
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What job categories do people searching Remote Biotech Regulatory Affairs jobs look for? The top searched job categories for Remote Biotech Regulatory Affairs jobs are:
Remote Biotech Regulatory Affairs jobs near you
Infographic showing various Remote Biotech Regulatory Affairs job openings in the United States as of July 2026, with employment types broken down into 72% Full Time, 25% Part Time, 1% Temporary, and 2% Contract. Highlights an 75% Physical, 2% Hybrid, and 23% 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

Posted 18 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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