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Regulatory Submission Jobs (NOW HIRING)

Jobtailor

Regulatory Affairs Manager

Lake Forest, IL · On-site

$130 - $170/hr

Oversee the preparation, review and submission of data and documentation to support regulatory applications, product registrations. * Establishes and manages systems and processes to support ...

Sapta Global Inc

Regulatory Analyst

Signal Hill, CA · On-site

Regulatory Submissions Management and Operations for Janssen R&D Project Goal (Mandatory): The management and delivery of regulatory submissions to global health authorities required to support the ...

Vrtx

Associate Director, Global Submission Management

Boston, MA · Hybrid

$163K - $244K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables * Coordinates crossfunctional ...

Premier Research

Senior Regulatory Submissions Lead

  • Medical

  • Retirement

  • PTO

Own submission documentation and regulatory content quality by preparing, reviewing, and securing ... sponsor approval of core submission documents such as application forms, cover letters, Patient ...

Vrtx

Director, Global Submission Management

Boston, MA · Hybrid

$190K - $285K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables * Coordinates crossfunctional ...

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Regulatory Submission information

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$40.5K

$95.4K

$138.5K

How much do regulatory submission jobs pay per year?

As of Aug 12, 2026, the average yearly pay for regulatory submission in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

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

To thrive as a Regulatory Submission professional, you need a solid understanding of regulatory requirements, attention to detail, and experience in preparing, compiling, and submitting documents to regulatory authorities—often requiring a degree in life sciences or a related field. Familiarity with submission management systems (such as eCTD or Veeva Vault), strong document management skills, and sometimes certifications like RAPS are valuable assets. Strong organizational abilities, effective written communication, and the capacity to collaborate cross-functionally distinguish standout candidates. These competencies ensure timely, accurate, and compliant submissions, which are vital for regulatory approval and the successful progress of products to market.

What are the primary day-to-day responsibilities of someone working in regulatory submission?

A professional in Regulatory Submission is typically responsible for compiling, reviewing, and submitting regulatory documents to agencies such as the FDA or EMA to support product approvals or ongoing compliance. Their daily tasks often include coordinating with cross-functional teams (such as clinical, quality, and legal departments), tracking deadlines, and maintaining documentation to meet regulatory standards. They must closely monitor regulatory changes and ensure submissions are updated accordingly. This role may also oversee the management of electronic submission systems and address queries or deficiencies from regulatory authorities. Overall, the position offers regular opportunities to collaborate and play a pivotal part in a company's product development lifecycle.

What is a regulatory submission?

A Regulatory Submission job involves preparing, compiling, and submitting documents to regulatory authorities to gain approval for products, such as pharmaceuticals, medical devices, or biotechnology innovations. Professionals in this role ensure that submissions comply with regulatory requirements, guidelines, and timelines. They work closely with cross-functional teams, including regulatory affairs, clinical, and quality assurance teams, to gather necessary data and documentation. The role requires strong attention to detail, knowledge of global regulatory standards, and effective communication skills to liaise with regulatory agencies.

More about Regulatory Submission jobs
What are the most commonly searched types of Regulatory Submission jobs? The most popular types of Regulatory Submission jobs are:
What states have the most Regulatory Submission jobs? States with the most job openings for Regulatory Submission jobs include:
What job categories do people searching Regulatory Submission jobs look for? The top searched job categories for Regulatory Submission jobs are:
Regulatory Submission jobs near you
Infographic showing various Regulatory Submission job openings in the United States as of August 2026, with employment types broken down into 92% Full Time, 4% Part Time, and 4% Temporary. Highlights an 100% In-person job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Senior Regulatory Submission Lead

Penfield Search Partners

Palo Alto, CA

$120 - $175/hr

Full-time

Posted 20 days ago

Job description

Contact: Alexandra Spink -
No 3rd party candidates
Location: Bay Area-based role
Work Model: 5 days onsite per week

We are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module 5. This 1 year contract role will provide hands-on submission execution and cross-functional coordination to ensure regulatory content is aligned, complete, and ready for filing.

Key Responsibilities

  • Coordinate BLA submission activities across Module 2 and Module 5, including timelines, deliverables, and submission readiness.
  • Support preparation and review of submission content, including CSRs, appendices, ISS, ISE, and related regulatory documentation.
  • Ensure clinical and biometrics outputs are incorporated into accurate, regulatory-ready submission content.
  • Manage submission documentation, QC, version control, and workflows within Veeva Vault.
  • Support eCTD publishing activities and FDA-facing submission needs.
  • Identify gaps, track dependencies, and help maintain submission timelines.

Qualifications

  • 7+ years of experience supporting regulatory submissions within the life sciences industry.
  • Advanced scientific or clinical training preferred (PhD, PharmD, or MD), with prior ophthalmology experience strongly preferred.
  • Hands-on BLA submission experience with strong knowledge of FDA Module 2 and Module 5 requirements.
  • Experience independently coordinating submission activities from planning through filing, including FDA interactions and regulatory communications.
  • Hands-on experience using Veeva Vault to support regulatory submissions, including document management, workflows, QC, and submission readiness, with a strong understanding of eCTD processes and publishing activities.

Success in This Role
The successful candidate will quickly step into an active BLA submission environment, coordinate across functions, and help ensure Module 2 and Module 5 deliverables remain aligned and submission-ready through filing.
Hourly Rate: $120-$175/hour