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Regulatory Fda Remote Jobs (NOW HIRING)

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA / US Remote Work Arrangement: Remote Compensation:

Alston

FDA Technical Consultant

Washington, DC · On-site +1

This role offers flexibility to work hybrid or a fully remote arrangement. Candidates should be ... Collaborate with cross-functional teams at the Firm and at the client including legal, regulatory ...

Dentsply Sirona, Inc

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre ...

Mercor

Regulatory Counsel

New York, NY · Remote

$85 - $120/hr

Remote Commitment: 20-40 hours/week Role Responsibilities * Design realistic regulatory scenarios ... Familiarity with regulatory portals like FDA , federalregister.gov , NLRB.gov , EEOC . Start Date

RadNet

Sr Regulatory Affair Principal

Somerville, MA · On-site +1

Lead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions ... Working Environment Remote. This position requires domestic / international travel up to 15%

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How much do regulatory fda remote jobs pay per hour?

As of Jun 21, 2026, the average hourly pay for regulatory fda remote 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 the difference between Regulatory Fda Remote vs Regulatory Affairs Specialist?

AspectRegulatory Fda RemoteRegulatory Affairs Specialist
CertificationsFDA-related certifications, such as CDRH or CDRH-specific trainingRegulatory affairs certifications, like RAC or RAPS
Work EnvironmentPrimarily remote, focusing on FDA compliance documentation and submissionsOften office-based or hybrid, involved in broader regulatory strategies
Industry UsageCommon in medical device, pharmaceutical, and biotech companiesUsed across healthcare, medical devices, and pharmaceutical sectors

While both roles involve regulatory compliance, Regulatory Fda Remote positions focus specifically on FDA submissions and documentation remotely, whereas Regulatory Affairs Specialists handle broader regulatory strategies and may work onsite or hybrid. The roles often overlap in certifications and industry applications, but their scope and work environment differ.

What does a Regulatory FDA Remote professional do?

A Regulatory FDA Remote professional is responsible for ensuring that a company’s products—such as pharmaceuticals, medical devices, or food items—comply with all U.S. Food and Drug Administration (FDA) regulations and guidelines. Working remotely, they prepare and submit regulatory documents, communicate with regulatory agencies, and interpret FDA requirements for their organization. Their work helps companies achieve and maintain approval for their products while minimizing regulatory risks. This role often involves collaborating with product development, quality assurance, and legal teams to ensure ongoing compliance.

How does working remotely in a Regulatory FDA role impact collaboration with cross-functional teams?

Remote Regulatory FDA professionals frequently collaborate with colleagues in clinical, legal, quality, and scientific departments through virtual meetings, shared platforms, and cloud-based document management systems. To remain effective, strong communication skills and proactive scheduling are essential, as regulatory deadlines often require swift, coordinated responses. While being remote allows flexibility, it can also present challenges in staying updated with rapidly changing regulations and ensuring alignment with team objectives. Regular check-ins and clear documentation help maintain workflow efficiency and compliance.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Specialist (FDA Remote), and why are they important?

To thrive as a Regulatory Affairs Specialist (FDA Remote), you need a solid understanding of FDA regulations, submission processes, and typically a degree in life sciences or a related field. Familiarity with regulatory submission tools such as eCTD, regulatory databases, and document management systems is essential. Strong attention to detail, effective written communication, and organizational skills help professionals excel in remote, deadline-driven environments. These skills ensure accurate and timely regulatory filings, compliance with changing guidelines, and effective collaboration with internal and external stakeholders.
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What cities are hiring for Regulatory Fda Remote jobs? Cities with the most Regulatory Fda Remote job openings:
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Regulatory Fda Remote jobs near you
Infographic showing various Regulatory Fda Remote job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 95% Full Time, 1% Part Time, and 3% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Associate Director, Regulatory CMC

Associate Director, Regulatory CMC

Vaxcyte

San Carlos, CA • On-site, Remote

$180K - $210K/yr

Other

Posted 24 days ago

Job description

Summary:

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations.  

Essential Functions:

  • Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
  • Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
  • Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
  • Provides CMC regulatory guidance to cross-functional teams and key stakeholders
  • Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development
  • Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
  • Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
  • Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
  • Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Requirements:

Bachelor's Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered.

  • Prior experience preparing/authoring CMC DS sections:
    • BLA highly preferred.
    • Post-approval supplements/variations highly preferred.
    • INDs/IMPDs.
  • Prior development or manufacturing experience is a plus.
  • Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
  • Excellent interpersonal skills to communicate difficult concepts.
  • Strategic thinking and strong problem-solving skills
  • Collaborates and communicates in an open, clear, complete, timely, and consistent manner
  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Reports to: Executive Director, CMC Regulatory
 
Location: San Carlos, CA / US Remote
 
Work Arrangement: Remote
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary.
 
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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