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Remote Biotech Regulatory Affairs Jobs (NOW HIRING)

Veristat

$128K - $169K/yr

Flexible, inclusive culture - 70% remote workforce, 66% women-led teams Learn more about our core ... with pharmaceutical / biotech companies. * Demonstrated ability to lead by example with ...

Vaxcyte

Sr. Manager, Regulatory Affairs

San Carlos, CA ยท 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 ...

Veristat

Director, Regulatory Affairs

Charleston, WV ยท Remote

$138K - $183K/yr

Flexible, inclusive culture - 70% remote workforce, 66% women-led teams Learn more about our core ... with pharmaceutical / biotech companies. * Demonstrated ability to lead by example with ...

Oscar Health

Analyst, Regulatory Affairs

Dallas, TX ยท 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

Atlanta, GA ยท 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 ...

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 ...

Stryker

Senior Specialist, Regulatory Affairs

Portage, MI ยท On-site +1

$108K - $180K/yr

Remote or Hybrid or Onsite Stryker is hiring a Senior Specialist, Regulatory Affairs . Join a team ... Minimum 2 years of experience in regulatory affairs within the medical device, biotechnology ...

Oscar Health

Analyst, Regulatory Affairs

Dallas, TX ยท 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

Atlanta, GA ยท 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 ...

Travere

Manager, Regulatory Affairs Strategy

San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... biotechnology industry. * Experience supporting clinical-stage development programs and global ...

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

As of Sep 2, 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 is a remote biotech regulatory affairs professional?

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.

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.

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Remote Biotech Regulatory Affairs jobs near you
Infographic showing various Remote 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.

Executive Director, Regulatory Affairs - Global Regulatory Leader

Summit Therapeutics

Remote

$153K - $202K/yr

Full-time

Re-posted 28 days ago

Job description

Overview of Role:

The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area.

Role and Responsibilities:

  • Act independently to lead global regulatory strategies for assigned products/indications through all phases of development to include regulatory approvals/product launches, and post-marketing efforts, with little to no oversight.
  • Will represent Regulatory Affairs as relates to development collaborations and/or partnerships, to include leading due diligence as required supporting BD activities
  • For new indications assigned, will lead effort on behalf of regulatory cross-functionally with colleagues from clinical, biostatistics, commercial, medical affairs, clinical pharmacology, safety, and others. Expected to provide material (content) input into potential study synopses and corresponding global regulatory briefing documents.
  • Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy.
  • Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
  • Key internal leader and driver of regulatory policy and strategy for assigned products
  • Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
  • Lead labeling strategy for given product(s)/indication(s), in support of initial license applications through post-marketing
  • Demonstrates excellent understanding of drug development and leadership behaviors consistent with the level
  • Accountable for ensuring that corporate goals are met with respect to assigned projects
  • Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members and extra-departmental colleagues
  • Will have direct reports and contributes to the performance management for other RA team members
  • May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate
  • Follows budget allocations

Experience, Education and Specialized Knowledge and Skills:

  • Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred.
  • Minimum of 15+ years of experience in pharmaceutical/biotech regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China.
  • Expected to have significant experience with direct involvement/leadership as relates to marketing/license applications (e.g., BLA, NDA, MAA), and given late-stage nature of Summit's clinical development program(s), experience supporting regulatory approvals and required activities in support of product launch and post marketing efforts.
  • Significant experience dealing with partners/collaborations directly
  • Requires drug development experience setting global regulatory strategy in alignment with cross functional peers to support company's corporate goals.
  • Minimum of 10+ years of proven experience in a strategic leadership role with strong project management skills
  • Experience interfacing with major government regulatory authorities
  • Strong communication and proactive negotiation skills
  • Communicate effectively and articulate complex ideas in an easily understandable way
  • Ability to successfully work in a fast-paced, demanding and collaborative environment
  • Travel up to approximately 5%

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