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Submissions Specialist Jobs (NOW HIRING)

IDRestore.com

Submissions Specialist

Naples, FL · On-site +1

Communicates with the submissions specialist to include any notes or special tasks to the submissions specialist. Works closely with Executive Management and Invoicing team and providing updates to ...

Danaher

Principal, RA Specialist

$110K - $135K/yr

The Principal Regulatory Affairs Specialist is responsible for developing and executing strategies ... Author and lead the creation of regulatory documents (regulatory submissions/filings, registration ...

Eagle

Sample Submission Specialist

Houston, TX · On-site

Position Summary The Sample Submission Specialist is responsible for the receipt, unboxing, logging, labeling, and organization of incoming samples in support of laboratory testing operations. This ...

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Submissions Specialist information

What is the difference between Submissions Specialist vs Data Entry Clerk?

AspectSubmissions SpecialistData Entry Clerk
Required CredentialsHigh school diploma, familiarity with submission platformsHigh school diploma or equivalent, basic computer skills
Work EnvironmentOffice setting, working with submission systems and documentationOffice or remote, entering data into databases or spreadsheets
Industry UsageHealthcare, legal, government, and education sectorsVarious industries including administrative, healthcare, and retail
Common Search/ComparisonYesNo

The Submissions Specialist focuses on managing and processing submissions within specific systems, ensuring compliance and accuracy. In contrast, Data Entry Clerks primarily input and update data across various platforms. While both roles require attention to detail and basic computer skills, the Submissions Specialist often involves specialized knowledge of submission procedures and industry-specific requirements.

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Infographic showing various Submissions Specialist job openings in the United States as of August 2026, with employment types broken down into 87% Full Time, 11% Part Time, and 2% Contract. Highlights an 78% Physical, 2% Hybrid, and 20% Remote job distribution.

Regulatory Submissions Specialist

New Haven, CT

Celldex Therapeutics
Biotechnology Research and Development • 201 - 500 employees
Learn more about Celldex Therapeuticsexternal

$76K - $99K/yr

Full-time

Medical, Retirement, PTO

Re-posted 4 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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