Remote Regulatory Operations Specialist Jobs
Remote Regulatory Operations Specialist jobs are open across the U.S. at remote-first firms and distributed teams in life sciences, pharmaceuticals, medical devices, and financial services. Employers hiring remotely right now include Oscar Management Corporation, Erasca, and argenx. See the openings below and apply to the ones that match your experience.
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Showing 5 of 16+ Remote Regulatory Operations Specialist jobs
SUMMARY/JOB PURPOSE
Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management for clinical and commercial programs. Provide eCTD technical expertise and manage submission plans in Veeva RIM to ensure timely, high-quality submissions that meet Health Authority requirements and company standards. Implement evolving FDA requirements and collaborate on process, technology and automation improvements to enhance efficiency, compliance and scalability.
ESSENTIAL DUTIES/RESPONSIBILITIES
- Independently format, publish, transmit and archive Health Authority submission types, ensuring submissions are high quality, compliant and delivered according to established timelines.
- Serve as subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools, as applicable.
- Provide Regulatory Operations expertise and guidance on eCTD structure, content readiness, publishing requirements, validation, dispatch and lifecycle management in accordance with Health Authority requirements.
- Perform document- and submission-level technical quality control to ensure completeness, consistency, accuracy and compliance with company standards and regulatory requirements.
- Identify IT solutions to enhance Regulatory Operations capabilities in document formatting and submission publishing, automation opportunities and technology enhancements that improve submission quality, efficiency, compliance and scalability.
- Create regulatory submission objectives, submission content plans, and documentation within Veeva RIM.
- Routinely participate in the review of evolving FDA electronic submission requirements and technical standards, assess operational impact and implement changes as appropriate.
- Collaborate within Regulatory Operations on SOPs, work instructions, templates, checklists, standards and best practices that support consistent and efficient Regulatory Operations processes.
- Performs other duties as assigned
- Complies with all policies and standards
SUPERVISORY RESPONSIBILITIES
- None.
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
Education
- Bachelor’s degree in related discipline and a minimum of nine years of related experience; or,
- Master’s degree in related discipline and a minimum of seven years of related experience; or,
- PhD degree in related discipline and a minimum of two years of related experience; or,
- Equivalent combination of education and experience.
Knowledge, Skills and Abilities
Required:
- Subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools.
- Manages time and resources to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.
- Applies knowledge of the regulatory framework and industry practices to complete routine work.
- Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to small groups of departmental colleagues.
- Good interpersonal skills and emerging ability to accommodate differing views to support the development of an agreed upon resolution.
- Works collaboratively with team members to achieve common objectives. Engages internal stakeholders to establish collaborative relationships.
- Applies knowledge of organizational objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
- Leads self by managing and executing own work. Acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.
Travel Requirements
- 20% Travel approximately 20%
#LI-MB1
Location: Remote Range for this position: $165,000 - $208,500 The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
Exelixis is an Equal Opportunity Employer. We are committed to fostering an inclusive environment where everyone can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy (including lactation, childbirth, or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, citizenship or immigration status, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other characteristic protected by applicable federal, state, or local law. We are also committed to providing reasonable accommodations to qualified individuals with disabilities, unless undue hardship and/or a direct threat to the health and/or safety of the individual or others would result.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com.
Exelixis is an E-Verify employer.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
SUMMARY/JOB PURPOSE
Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management for clinical and commercial programs. Provide eCTD technical expertise and manage submission plans in Veeva RIM to ensure timely, high-quality submissions that meet Health Authority requirements and company standards. Implement evolving FDA requirements and collaborate on process, technology and automation improvements to enhance efficiency, compliance and scalability.
ESSENTIAL DUTIES/RESPONSIBILITIES
- Independently format, publish, transmit and archive Health Authority submission types, ensuring submissions are high quality, compliant and delivered according to established timelines.
- Serve as subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools, as applicable.
- Provide Regulatory Operations expertise and guidance on eCTD structure, content readiness, publishing requirements, validation, dispatch and lifecycle management in accordance with Health Authority requirements.
- Perform document- and submission-level technical quality control to ensure completeness, consistency, accuracy and compliance with company standards and regulatory requirements.
- Identify IT solutions to enhance Regulatory Operations capabilities in document formatting and submission publishing, automation opportunities and technology enhancements that improve submission quality, efficiency, compliance and scalability.
- Create regulatory submission objectives, submission content plans, and documentation within Veeva RIM.
- Routinely participate in the review of evolving FDA electronic submission requirements and technical standards, assess operational impact and implement changes as appropriate.
- Collaborate within Regulatory Operations on SOPs, work instructions, templates, checklists, standards and best practices that support consistent and efficient Regulatory Operations processes.
- Performs other duties as assigned
- Complies with all policies and standards
SUPERVISORY RESPONSIBILITIES
- None.
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
Education
- Bachelor’s degree in related discipline and a minimum of nine years of related experience; or,
- Master’s degree in related discipline and a minimum of seven years of related experience; or,
- PhD degree in related discipline and a minimum of two years of related experience; or,
- Equivalent combination of education and experience.
Knowledge, Skills and Abilities
Required:
- Subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools.
- Manages time and resources to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.
- Applies knowledge of the regulatory framework and industry practices to complete routine work.
- Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to small groups of departmental colleagues.
- Good interpersonal skills and emerging ability to accommodate differing views to support the development of an agreed upon resolution.
- Works collaboratively with team members to achieve common objectives. Engages internal stakeholders to establish collaborative relationships.
- Applies knowledge of organizational objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
- Leads self by managing and executing own work. Acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.
Travel Requirements
- 20% Travel approximately 20%
#LI-MB1
Location: Remote Range for this position: $165,000 - $208,500 The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
Exelixis is an Equal Opportunity Employer. We are committed to fostering an inclusive environment where everyone can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy (including lactation, childbirth, or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, citizenship or immigration status, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other characteristic protected by applicable federal, state, or local law. We are also committed to providing reasonable accommodations to qualified individuals with disabilities, unless undue hardship and/or a direct threat to the health and/or safety of the individual or others would result.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com.
Exelixis is an E-Verify employer.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
See All 16 Remote Regulatory Operations Specialist Jobs
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Find JobsRemote Regulatory Operations Specialist Job Market
Who's Hiring
Top Industries Hiring
- Insurance
What Employers Look For
The qualifications that appear most often in remote regulatory operations specialist jobs.
- Bachelor's degree in life sciences, regulatory affairs, or a related field
- Experience with regulatory submissions such as INDs, NDAs, BLAs, or 510(k)s
- Proficiency with electronic document management and submission publishing systems
- Knowledge of FDA regulations, ICH guidelines, or applicable industry standards
- Regulatory Affairs Certification (RAC) from RAPS preferred for senior roles
- Strong attention to detail with demonstrated ability to manage multiple concurrent submissions
Tips for Your Remote Regulatory Operations Specialist Job Search
Apply early to remote roles that fit
Migrate Mate lists remote regulatory operations specialist openings from across the U.S. in one place. Check it regularly and apply to roles that match your regulatory background directly, since competitive remote openings in this field fill quickly.
Show async documentation skills upfront
Remote regulatory operations employers prioritize candidates who communicate complex compliance information clearly in writing. Lead with writing samples, submission summaries, or SOPs you have authored to demonstrate you can work effectively without real-time direction.
Highlight remote-ready regulatory tools
Name the specific platforms you use, including eCTD authoring tools, regulatory information management systems, and document management platforms. Remote hiring managers screen resumes for fluency with the exact tools their distributed teams already rely on.
Prepare for async-heavy interview processes
Many distributed regulatory teams use asynchronous screening steps before live interviews. Practice delivering concise written responses to scenario questions about submission timelines, agency interactions, and cross-functional coordination to perform well in every stage.
Remote Regulatory Operations Specialist Jobs: Frequently Asked Questions
How do I get a remote regulatory operations specialist job?
Target companies that already operate distributed regulatory teams, including remote-first life sciences firms, SaaS-based compliance platforms, and global medical device manufacturers. Remote employers screen heavily for self-direction, precise written communication, and familiarity with regulatory information management systems and electronic submission tools. Candidates who demonstrate async collaboration skills and a clean record of managing submissions or regulatory documentation independently stand out most.
Which companies hire remote regulatory operations specialists?
Remote regulatory operations specialist roles are posted by Oscar Management Corporation, Erasca, and argenx and others right now, based on current remote listings on Migrate Mate as of November 2026. The employers doing the most remote hiring in this role tend to be distributed pharmaceutical, biotech, and medical device organizations alongside compliance technology companies with teams across multiple time zones.
Can you get a remote regulatory operations specialist job with no experience?
Yes, but remote entry-level roles are harder to land because employers expect you to manage regulatory workflows independently from day one. Remote-first biotech startups and contract research organizations occasionally hire junior candidates who can show completed regulatory affairs coursework, hands-on experience with submission systems like eCTD tools, or relevant internships. A portfolio of documentation samples or a demonstrated understanding of regulatory pathways helps close the experience gap.
Do you need a degree for remote regulatory operations specialist jobs?
Not always, though most remote employers prefer a bachelor's degree in a life sciences, health, or related field. What matters most to remote hiring managers is demonstrated ability to manage regulatory submissions, interpret guidance documents accurately, and work without close supervision. Candidates with relevant certifications, hands-on regulatory experience, or strong records in adjacent compliance roles can compete effectively even without a four-year degree.
Which industries hire the most remote regulatory operations specialists?
The sectors hiring the most remote regulatory operations specialists are Insurance, based on current remote listings on Migrate Mate as of November 2026. These industries rely on distributed regulatory teams to manage submissions, maintain compliance documentation, and coordinate across global stakeholders without requiring specialists to be on-site.
See All 16 Remote Regulatory Operations Specialist Jobs
Find roles that match your experience and apply in just a few clicks.
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