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Regulatory Submissions Manager Jobs in Rutherford, NJ

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

S. and international regulatory activities, including regulatory submissions, inspections and ... Also performs active management and observations of staff for compliance with regulations and ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

S. and international regulatory activities, including regulatory submissions, inspections and ... Also performs active management and observations of staff for compliance with regulations and ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

S. and international regulatory activities, including regulatory submissions, inspections and ... Also performs active management and observations of staff for compliance with regulations and ...

Eikon Therapeutics

Director, Regulatory Affairs

Jersey City, NJ · On-site

$213K - $257K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Submission Management: Lead and/or support the preparation, review, and submission of regulatory documents, including INDs, NDAs, and MAAs, as applicable. * Cross-Functional Collaboration: Work ...

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Showing results 21-40

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 Affairs Associate

Stark Pharma Solutions Inc

Piscataway, NJ • On-site

Contractor

Re-posted 16 days ago

Job description

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Role: Regulatory Affairs Associate

Location: United States

Duration: Long Term contract

Position Summary

We are seeking a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology products, or combination products. The successful candidate will assist in preparing regulatory submissions, maintaining regulatory documentation, monitoring compliance requirements, and supporting product registrations to ensure adherence to FDA and global regulatory standards.

Key Responsibilities

  • Prepare, compile, review, and submit regulatory documentation to support product approvals and registrations.
  • Assist in the preparation of FDA submissions, including 510(k), PMA, IND, NDA, ANDA, or other regulatory filings as applicable.
  • Support regulatory strategy development for new products, product modifications, and market expansions.
  • Maintain regulatory files, product registrations, licenses, and submission records.
  • Review product labeling, promotional materials, and technical documentation for regulatory compliance.
  • Monitor changes in U.S. and international regulations and communicate regulatory impacts to internal stakeholders.
  • Collaborate with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to support regulatory initiatives.
  • Assist with regulatory agency correspondence, inspections, audits, and information requests.
  • Support change control assessments and evaluate regulatory impact of product or process changes.
  • Participate in cross-functional project teams to ensure timely regulatory deliverables.

Required Qualifications

  • Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline.
  • 1–3 years of Regulatory Affairs experience within the pharmaceutical, biotechnology, medical device, or healthcare industry.
  • Working knowledge of FDA regulations, guidance documents, and regulatory submission processes.
  • Strong technical writing, documentation, and organizational skills.
  • Ability to manage multiple projects and deadlines in a fast-paced environment.
  • Excellent verbal and written communication skills.