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Regulatory Submissions Jobs (NOW HIRING)

Sapta Global Inc

Regulatory Analyst

Signal Hill, CA

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 ...

CEDENT

Regulatory Manager

Boston, MA

You will oversee the preparation and submission of regulatory documents, manage relationships with regulatory agencies, and lead cross-functional teams to support regulatory activities across a ...

Nova Pneuma, Inc.

Director, Regulatory Affairs

Fremont, CA · On-site

$192K - $253K/yr

Develop and implement regulatory strategies for successful submission of product candidates from pre-IND stage through the product approval process. * Collaborate with project teams to ensure ...

Alexza

Director, Regulatory Affairs

Fremont, CA · On-site

$192K - $253K/yr

Develop and implement regulatory strategies for successful submission of product candidates from pre-IND stage through the product approval process. * Collaborate with project teams to ensure ...

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 ...

Doist

Manager, Regulatory Affairs

Pleasanton, CA · On-site

$150 - $180/hr

S. regulatory submissions, including 510(k) submissions and other applicable premarket activities * Support international regulatory submissions and registrations across applicable global markets

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Regulatory Submissions information

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$18

$39

$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 Analyst

Sapta Global Inc

Signal Hill, CA

Contractor

Re-posted 25 days ago

Job description

Project Title (Mandatory): 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 maintenance, development, and registration of products Project Timing (Mandatory): January 01, 2022 – December 31, 2022 Services Location (Mandatory): Services will be performed at Buyer’s facility at the following location: 1125 Trenton-Harbourton Rd, Titusville, NJ 08560 920 Route 202 South, Raritan, NJ 08869 Deliverables to be performed: · Establish Dossier Plans for the assigned global submission types as needed to support the lifecycle of one or more products. · Generate dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.· Ensure relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate. · Ensure dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools. · Support development of departmental work practices, process enhancements, and associated training materials.· Develop/maintain associated process tools and relevant training documentation.· Support compliance needs as appropriate. Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements; Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission; Participate on special projects and process improvement initiatives, as needed.
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About Sapta Global

Sourced by ZipRecruiter

Sapta Global is headquartered in Woodbridge, New Jersey. We are a women owned, SBA 8(a) certified company with innovative Consulting Solutions and Services firm that is dedicated to helping companies realize improved outcomes from the investments they’ve made in their Associates, Systems and Business Processes. Sapta’s expertise in professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world. We concentrate on our customer’s key business differentiators then match relevant solutions and services that help extend the company’s value in the market. Through our unique Global delivery model and innovative design approach, we provide high value Information Services that enable our clients to enhance their business performance and increase their productivity. Our Technology advantage is the process design expertise we use from the start of our work that integrates our customer’s Strategy with their business goals. Our project management skills, software engineering practices that are integrated with software quality assurance methodologies delivers innovative solutions that provides our customers a competitive advantage.

Company size

1,001 - 5,000 Employees

Headquarters location

Woodbridge, NJ, US

Year founded

2003

Social media

Twitter

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