ZipRecruiter

Log In

1

Regulatory Submissions Manager Jobs in Basking Ridge, NJ

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site +1

$154K - $204K/yr

Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies * Plays a key role in ...

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies * Plays a key role in ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals * Responsible for the preparation of all ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals * Responsible for the preparation of all ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · Remote

$153K - $202K/yr

... Manages the preparation and submission of formal CMC-related regulatory meeting requests and briefing packages and coordinates meetings with regulatory agenciesLeads CMC-related FDA meetings and ...

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

High-level management of regulatory projects as assigned, assistance in the development of regulatory submission timelines, and ensuring execution to meet corporate goalsOversee the timelines, review ...

Englewood Lab

Quality - Regulatory Affairs Manager

Totowa, NJ · On-site

$90K - $120K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Regulatory Affairs Manager Location: Totowa, NJ (Onsite) Employment Type: Full-Time | Exempt ... This role oversees regulatory compliance, submissions, facility registrations, and cross-functional ...

Eikon Therapeutics

Director, Regulatory Affairs

Jersey City, NJ

$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 ...

next page

Showing results 1-20

All JobsRegulatory Submissions JobsRegulatory Submissions Manager JobsRegulatory Submissions Manager Jobs in Basking Ridge, NJ

Regulatory Submissions Manager information

See Basking Ridge, NJ salary details

$56.2K

$114.1K

$187.6K

How much do regulatory submissions manager jobs pay per year?

As of Aug 20, 2026, the average yearly pay for regulatory submissions manager in Basking Ridge, NJ is $114,116.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,900.00 and $140,700.00 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 are popular job titles related to Regulatory Submissions Manager jobs in Basking Ridge, NJ?

For Regulatory Submissions Manager jobs in Basking Ridge, NJ, the most frequently searched job titles are:

What job categories do people searching Regulatory Submissions Manager jobs in Basking Ridge, NJ look for?

The top searched job categories for Regulatory Submissions Manager jobs in Basking Ridge, NJ are:

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

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

Regulatory Submissions Manager jobs near you

Director, US Regulatory Affairs

Altimmune

Morristown, NJ • On-site, Remote

$154K - $204K/yr

Full-time

Re-posted 19 days ago

Job description

Workplace Designation:

Depending upon location, this role will be hybrid or remote and will require some travel as business needs dictate.

Summary of Position:

This individual will be responsible for providing strategic regulatory advice and oversight for all of Altimmune's US regulatory applications, including the preparation and management of relevant clinical, nonclinical, advertising, promotional, and labeling aspects of relevant US regulatory submissions, responses, and correspondence. This role will act as the main point of contact and liaison with the US FDA. This position reports to the Vice President, Regulatory Affairs.

Essential Functions:

  • High-level management of regulatory projects as assigned, assistance in the development of regulatory submission timelines, and ensuring execution to meet corporate goals
  • Oversee the timelines, review, and compilation of IND, BLA, NDA, promotional, and lifecycle submissions, including any safety reporting, as required
  • Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies
  • Plays a key role in the development of regulatory strategy and writing of regulatory submissions
  • Interprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligence
  • Attends relevant FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune's product development programs
  • Plays a leading role in the development, review, and implementation of departmental SOPs and processes
  • Other duties as assigned.
Job Requirements (essential knowledge, skills, and attributes):
  • Minimum education Bachelor's degree in science, engineering, or a health-related field required with at least 6 years of regulatory experience in the biotech/pharma industry, or a Ph.D., MD, PharmD with at least 6 years of regulatory experience
  • Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies
  • Thorough knowledge of FDA regulations and global regulatory guidelines governing clinical development, clinical trial applications, marketing, and post-approval application submissions. Prior experience reviewing and submitting advertising and promotional materials for drugs and biological products is preferred
  • Excellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneously
  • Must be self-motivated with a positive attitude and the ability to work well with others
  • Excellent oral and written communication skills.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Apply