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Regulatory Submissions Jobs (NOW HIRING)

Premier Research

Senior Regulatory Submissions Lead

Premier Research is looking for a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team. You will help biotech, medtech, and specialty pharma companies transform ...

Tempus

Manager, Regulatory Submissions (Remote)

Chicago, IL · On-site +1

$110K - $150K/yr

Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc. * Establishing ...

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Regulatory Submissions information

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$62

How much do regulatory submissions jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for regulatory submissions 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 regulatory submissions?

Regulatory submissions are formal documents or packages of information that organizations, such as pharmaceutical or medical device companies, submit to government agencies to obtain approval for products, clinical trials, or changes to existing products. These submissions must comply with specific regulatory requirements and formats, and may include data on safety, efficacy, quality, and manufacturing processes. Common regulatory agencies include the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and others, depending on the region. The process helps ensure that products are safe and effective for public use before they reach the market.

What are some common challenges faced by professionals working in regulatory submissions?

Regulatory Submissions professionals often navigate complex and evolving regulations across different regions, which can be challenging when preparing documentation for multiple authorities. Managing tight deadlines, coordinating input from cross-functional teams (such as clinical, quality, and legal departments), and ensuring data accuracy are key aspects of the role. Additionally, adapting to varying submission formats and requirements for each regulatory body demands strong attention to detail and organizational skills. Overcoming these challenges is essential to facilitate timely product approvals and maintain compliance.

What are the key skills and qualifications needed to thrive in regulatory submissions, and why are they important?

To thrive in Regulatory Submissions, you need a strong understanding of regulatory guidelines, document management, and scientific or clinical background, often supported by a degree in life sciences or a related field. Familiarity with electronic submission platforms (eCTD), regulatory databases, and tools like Adobe Acrobat and Microsoft Office is typically required. Attention to detail, organizational skills, and effective written and verbal communication set professionals apart in this role. These skills ensure accurate, timely submissions and facilitate compliance with global regulatory requirements, which is critical for product approvals and company success.

What is the difference between Regulatory Submissions vs Regulatory Affairs Specialist?

AspectRegulatory SubmissionsRegulatory Affairs Specialist
Primary RolePreparing, submitting, and managing regulatory documents to authoritiesDeveloping regulatory strategies, ensuring compliance, and liaising with agencies
Required CredentialsTypically degrees in life sciences, certifications like RACSimilar credentials, often with additional experience in regulatory strategy
Work EnvironmentRegulatory departments within pharmaceutical or biotech companiesRegulatory teams across industries, including healthcare and medical devices

While Regulatory Submissions focus on preparing and managing specific documents for approval, Regulatory Affairs Specialists oversee broader compliance strategies and interactions with regulatory agencies. Both roles require similar credentials and often work closely within the same industry, but their scope and responsibilities differ.

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Regulatory Submissions jobs near you
Infographic showing various Regulatory Submissions job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Submissions Specialist

Celldex Therapeutics

New Haven, CT • On-site

$76K - $99K/yr

Full-time

Medical, Retirement, PTO

Posted 29 days ago

Job description

The Regulatory Submissions Specialist is responsible for the paper and electronic compilation and submission of Regulatory submissions and maintaining submission information in the proper RA repositories. The Regulatory Submissions Specialist will assist the regulatory affairs personnel for ensuring all publishing and QC processes are followed and all submission requirements are met prior to dispatching or submitting to the Health Authority.


  • Work with regulatory staff to prepare, assemble, process, format, quality control, publish, submit and archive submissions (e.g., IND, CTA, BLA, Amendments, Supplements, Annual Reports, IMPD and Briefing Documents) to US, CA and other international health authorities using advanced electronic publishing software (eCTD Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions.
  • Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission readiness and compliance
  • Generate regulatory submissions on time and in compliance with Company standards and regional regulatory agency regulations.
  • Assist with troubleshooting system issues
  • Assist with developing best practices in submission publishing and enhancing process efficiency
  • Archive documents according to archiving and document retention regulations

  • A minimum of 1 year of regulatory affairs electronic publishing experience preferred; other relevant experience with clinical trial documentation and electronic systems will be considered.
  • Experience with IND, CTA, BLA submissions
  • eCTD paperless submission experience using agency electronic submission’s gateway (ESG)
  • Experience preparing and submitting regulatory filings using Veeva RIMS
  • Proficient in MS Word formatting large documents and using template
  • EndNotes software experience a plus
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Ability to work in a fast paced environment and to handle multiple tasks
  • Capability to contribute to a team environment
  • Strong communication skills
  • The ability to work independently and as part of a team
  • Knowledge of publishing tools/systems in Pharma industry

The expected base salary for this position is: $76374.00 to $99188.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

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