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Submissions Jobs (NOW HIRING)

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 ...

Supports the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards * Ensures personal knowledge and understanding of global regulatory ...

Supports the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards * Ensures personal knowledge and understanding of global regulatory ...

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 ...

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Submissions information

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$5

$29

$41

How much do submissions jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for submissions in the United States is $29.10, according to ZipRecruiter salary data. Most workers in this role earn between $21.15 and $37.98 per hour, depending on experience, location, and employer.

What is a submissions role?

In the context of jobs, 'submissions' typically refer to the process of sending in required documents or materials, such as resumes, applications, portfolios, or proposals, for review. Employers or organizations use submissions to evaluate candidates or project ideas before making decisions. The term can also apply to the work submitted by employees or freelancers as part of their job duties or project deliverables. Proper submissions are crucial for meeting deadlines and ensuring your work is considered. Always follow the specified guidelines for submissions to increase your chances of success.

What are the key skills and qualifications needed to thrive as a submissions specialist?

To thrive as a Submissions Specialist, you need strong attention to detail, organizational skills, and a background in regulatory affairs or document management, often supported by a relevant degree. Familiarity with electronic submission systems (such as eCTD), regulatory databases, and document formatting tools is typically required. Excellent communication, time management, and problem-solving abilities help you coordinate with cross-functional teams and meet strict deadlines. These skills ensure the timely and accurate preparation, review, and submission of documents, which is critical for regulatory compliance and successful approvals.

What are some common challenges faced in a submissions role, and how can they be managed?

Professionals in Submissions roles often encounter tight deadlines and evolving regulatory requirements, which can make it challenging to ensure all documentation is accurate and compliant. Managing multiple submissions simultaneously across various regions or regulatory bodies can add complexity. Staying organized, maintaining clear communication with cross-functional teams (such as regulatory, clinical, and quality assurance), and keeping up-to-date with the latest guidelines are key strategies for success in this role.

What is the difference between Submissions vs Data Entry Clerk?

AspectSubmissionsData Entry Clerk
Required CredentialsVaries; often includes industry-specific certificationsHigh school diploma or equivalent; some roles may require basic certifications
Work EnvironmentOffice, remote, or online platformsOffice settings, data centers, or remote work
Employer & Industry UsageUsed across various industries for submitting documents, applications, or contentCommonly employed in administrative, healthcare, and finance sectors for inputting data
Search & Comparison IntentFocuses on submitting information or contentInvolves entering and managing data accurately

Submissions generally refer to the act of submitting documents, applications, or content, often requiring specific industry certifications. Data Entry Clerks focus on inputting and managing data within organizations, typically with basic qualifications. While both roles involve handling information, Submissions emphasizes the process of submitting, whereas Data Entry Clerks concentrate on data management and accuracy.

What cities are hiring for Submissions jobs?

Cities with the most Submissions job openings:

What are the most commonly searched types of Submissions jobs?

The most popular types of Submissions jobs are:

What states have the most Submissions jobs?

States with the most job openings for Submissions jobs include:

Infographic showing various Submissions job openings in the United States as of August 2026, with employment types broken down into 86% Full Time, 9% Part Time, 1% Temporary, and 4% Contract. Highlights an 84% Physical, 5% Hybrid, and 11% Remote job distribution, with an average salary of $60,519 per year, or $29.1 per hour.

Regulatory Submissions Specialist

Celldex Therapeutics

New Haven, CT • Hybrid

$76K - $99K/yr

Full-time

Medical, Retirement, PTO

Posted 26 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.
Compensation for this role 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.