ZipRecruiter

Log In

1

Regulatory Submissions Manager Jobs in Rutherford, NJ

Nuvation Bio, Inc.

Associate Director, Regulatory Affairs

NY · On-site +1

$190K - $200K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... regulatory submissions for Nuvation products. You will be responsible for... * Regulatory ... Responsible for the management, planning, coordination, and preparation of documents that are ...

Gsknch

Senior Manager, Regulatory Affairs - OTC

Warren, NJ · On-site

  • Medical

  • Retirement

Independently author regulatory submissions (e.g. NDAs, supplements, briefing documents, responses) * Lead interactions with FDA, including responses to Agency queries * Manage compliance within ...

previous page

Showing results 41-60

All JobsRegulatory Submissions JobsRegulatory Submissions Manager JobsRegulatory Submissions Manager Jobs in Rutherford, NJ

Regulatory Submissions Manager information

See Rutherford, NJ salary details

$55.6K

$112.9K

$185.5K

How much do regulatory submissions manager jobs pay per year?

As of Aug 20, 2026, the average yearly pay for regulatory submissions manager in Rutherford, NJ is $112,885.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,000.00 and $139,200.00 per year, depending on experience, location, and employer.

What is a regulatory submissions manager?

A Regulatory Submissions Manager is responsible for overseeing the preparation, compilation, and submission of regulatory documents to health authorities to ensure compliance with applicable laws and guidelines. They work closely with cross-functional teams, including regulatory affairs, clinical, and legal departments, to manage timelines and ensure accurate and timely filings. Their role includes maintaining awareness of regulatory requirements, coordinating responses to agency inquiries, and continuously improving submission processes. Effective communication, attention to detail, and knowledge of regulatory guidelines are key skills for success in this role.

What does a regulatory submissions manager do?

As a Regulatory Submissions Manager, your daily responsibilities often include preparing and reviewing regulatory submission documents, coordinating with internal teams (such as clinical, quality, and R&D), and managing submission timelines to ensure compliance with regulatory requirements. You will also track submission progress, respond to agency queries, and maintain up-to-date records of all communications and submission activities. The role may involve managing multiple projects simultaneously and problem-solving to address any regulatory challenges that arise. Regular collaboration with cross-functional teams is key to driving submissions forward smoothly and meeting critical deadlines.

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

To thrive as a Regulatory Submissions Manager, you need a strong background in regulatory affairs, scientific or technical disciplines, and project management, typically with a relevant bachelor’s or advanced degree. Familiarity with submission management systems such as eCTD, knowledge of FDA, EMA, or other regulatory guidelines, and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Exceptional attention to detail, organization, and strong written and verbal communication skills are vital for coordinating with cross-functional teams and ensuring timely submissions. These skills are essential for managing complex submission processes, maintaining compliance, and supporting successful product approvals.

What cities near Rutherford, NJ are hiring for Regulatory Submissions Manager jobs?

Cities near Rutherford, NJ with the most Regulatory Submissions Manager job openings:

Regulatory Submissions Manager jobs near you
Infographic showing various Regulatory Submissions Manager job openings in Rutherford, NJ as of August 2026, with employment types broken down into 84% Full Time, 15% Part Time, and 1% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution, with an average salary of $112,885 per year, or $54.3 per hour.

Regulatory Manager

Artech Information System LLC

East Hanover, NJ

Full-time

Re-posted 3 days ago

Job description

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Responsible for implementing regulatory strategy and managing operational activities for assigned regions.

Provides input into global regulatory strategy, including identification of gaps or risks in global strategic plan for assigned regions.

Partners with regions to align on regulatory strategy in order to fulfill business objectives

Represents DRA on or leads sub-teams as required.

Determines requirements and sets objectives for Health Authority (HA) interactions with regulatory lead

Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.

Develops and implements plans for timely response to HA requests and coordinates responses.

Drives coordination, planning, and submission of dossiers in assigned regions worldwide.

Review of global dossier summary documents.

Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).

Responsible for finalization and on time submission of annual reports and renewals across assigned regions.

Responsible for appropriate entering and quality of product specific attributes in compliance database.

Ensures regulatory compliance for project and keeps records of all major HA interactions in the validated document management system.

Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.


Skills:

Prior 2-4 years of regulatory experience required, ideally in US or EU

Strong knowledge of regulatory submission and approval processes, ideally in US or EU

Strong interpersonal, communication, negotiation and problem solving skills.

Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.

Proven ability to analyze and interpret efficacy and safety data.

Regulatory operational expertise


Qualifications

Science based BS or MS with requisite experience and demonstrated capability.

Additional Information

Richha Saini

Senior Clinical/Scientific Recruiter

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 

Office: 973.967.3439 | Fax: 973.998.2599

Connect with us on - LinkedIn | Facebook | Twitter



Artech logo

About Artech

Sourced by ZipRecruiter

Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).

Industry

Recruiting and staffing services

Company size

10,000+ Employees

Headquarters location

Morristown, NJ, US

Year founded

1992

View All Artech Jobs

Apply