ZipRecruiter

Log In

1

Regulatory Submissions Manager Jobs in Basking Ridge, NJ

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

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

Otsuka

Senior Manager, Regulatory Operations

Princeton, NJ · On-site

$150K - $224K/yr

Ensures submission and archival activities * Collaborates withalliance partners to achieve ... Certification (such as Regulatory Affairs Professionals Society (RAPS)) * Prior project management ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

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

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

previous pagenext page

Showing results 21-40

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

Senior Manager, North America Regulatory Liaison

Jj

Raritan, NJ • On-site

Full-time

Retirement, PTO

Posted 16 days ago

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, North America Regulatory Liaison. This position is a hybrid role and will be located in Spring House, PA; Titusville, NJ; or Raritan, NJ.

The Senior Manager, North America Regulatory Liaison will serve as a strategic regulatory leader, driving North America regulatory strategy and execution for assigned Immunology projects. This role will partner closely with global and cross-functional leaders to shape development pathways, influence key decisions, and ensure high-quality, timely interactions with Health Authorities. The position will require a strategic mindset, balancing risk mitigation with opportunity maximization to enable successful Immunology product development and lifecycle management.

The Senior Manager, North America Regulatory Liaison, will be responsible for leading the end-to-end planning, coordination and execution of assigned deliverables.

Principal Responsibilities:

Regulatory Strategy & Leadership:

  • Contribute to and help shape regulatory submission strategies, identifying risks, mitigation plans, and opportunities.

  • Provide strategic regulatory input into key development documents (e.g., clinical protocols, study reports, summaries).

  • Apply knowledge of regional and global regulatory frameworks, trends, and requirements across all phases of development.

Submission Planning & Execution:

  • Lead the planning, preparation, and delivery of regulatory submissions (simple to complex) across the product lifecycle.

  • Develop and maintain submission delivery timelines, content plans, and execution strategies.

  • Author and/or critically review submission components, ensuring quality and compliance.

  • Manage regulatory applications and associated procedures through Health Authority approvals.

Health Authority Engagement:

  • Serve as primary point of contact with Health Authorities (e.g., FDA).

  • Lead and coordinate Health Authority interactions, including preparation of briefing materials and responses.

  • Manage responses to regulatory queries and requests.

Cross-functional Collaboration:

  • Partner with global regulatory and cross-functional teams to align on submission and interaction plans.

  • Lead or contribute to cross-functional submission teams to ensure timely and effective execution.

  • Communicate clear, proactive status updates to stakeholders.

Operational Excellence & Influence:

  • Identify and drive process improvements, applying critical thinking and problem-solving skills.

  • Demonstrate strategic thinking, including contingency planning aligned with business objectives.

  • Influence decision-making across a matrixed organization.

Representation & Networking:

  • Represent the company externally with Health Authorities and industry partners, as appropriate.

  • Build and leverage strategic relationships and networks.

Additional Scope:

  • May serve as Regional Regulatory Leader for assigned programs.

Qualifications:

  • A minimum of a Bachelor's degree in a scientific or technical discipline is required. Advanced degree (Master's, PharmD, Ph.D.) in a scientific or technical discipline preferred.

  • A minimum of 8 years of relevant regulatory experience with a Bachelor's degree; a minimum of 6 years of relevant regulatory experience with a Master's or PharmD degree; or a minimum of 4 years of relevant regulatory experience with a Ph.D. is required.

  • Experience in pharmaceutical, biotech, or OTC industry is required.

  • Strong knowledge of clinical drug development and regulatory pathways is required.

  • Experience managing lifecycle submissions (e.g., IND, NDA, CTA, MAA) is required.

  • Demonstrated experience preparing, reviewing, and delivering regulatory documentation is required.

  • Proven track record interacting with FDA and other global Health Authorities is required.

  • Experience in Immunology therapeutic area preferred.

  • Experience in people management/coaching/mentoring is preferred.

  • Must have excellent communication and interpersonal skills.

  • Must have strong stakeholder management skills.

  • Must have the ability to exercise independent judgment in resolving complex regulatory and organizational challenges.

  • Must have strong leadership capabilities with the ability to work successfully in a matrixed environment.

  • The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.

  • The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.

  • This position may require up to 10% travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility

The anticipated base pay range for this position is :

$137,000.00 - $235,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Apply