Distinguished Scientist, CMC Regulatory Affairs - Combination Products

6084-Janssen Research & Development, LLC Legal Entity; Raritan (NJ); On-site; USD 168,000 - 291,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Parental Leave – 480 hours per year

Job summary

Johnson & Johnson is seeking a Distinguished Scientist, CMC Regulatory Affairs – Combination Products to lead regulatory strategy for novel drug-device programs across multiple sites in the United States. The role requires deep expertise in CMC, global submissions, and cross-functional program leadership.

You will partner with regulatory intelligence, policy, and senior stakeholders to ensure compliant strategies and timely submissions while mentoring teams and shaping external policy

Qualifications

• Bachelor’s degree in a scientific discipline required.
• Minimum 12 years of relevant experience in pharma/biotech/medical device or regulated healthcare.
• Demonstrated expertise in drug-device combination product regulatory strategy and submissions.

Responsibilities

• Lead strategic CMC regulatory strategies for novel, complex combination products and device-related programs.
• Provide regulatory guidance to cross-functional teams and external partners.
• Mentor and influence senior stakeholders; translate external developments into RA strategies.

Skills

Regulatory Affairs Management

Regulatory Compliance

Technical Writing

Strategic Thinking

Stakeholder Management

Cross-functional Collaboration

Education

Bachelor’s degree in biological/pharmaceutical/chemical/engineering/regulatory science/medical device

Job description

About Johnson & Johnson

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. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium R-108810, Poland R-108812, Switzerland R-108811, United States of America R-106742 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function and Locations

Job Function: Discovery & Pre-Clinical/Clinical Development

Job Sub Function: Regulatory Science

Job Category: Scientific/Technology

All Job Posting Locations: Horsham, Pennsylvania, United States of America, 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

We are searching for the best talent for our Distinguished Scientist, CMC Regulatory Affairs -Combination Products position, to be based in Raritan, New Jersey; Titusville, NJ; Horsham, PA; or Spring House, PA. Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.

Purpose: The Distinguished Scientist, CMC Regulatory Affairs – Combination Products provides scientific and CMC regulatory leadership for novel, ambiguous, and complex combination products and other drug-device development programs where combination product classification, device-related regulatory expectations are evolving, inconsistently applied across regions, or lack clear precedent. The role serves as a recognized CMC RA subject matter expert, drives innovative CMC regulatory strategies, advances regulatory knowledge sharing, and provides leadership in external policy‑shaping activities related to emerging combination product and device‑related regulatory expectations. The role partners with regulatory intelligence and policy stakeholders to identify gaps in combination product and device‑related regulatory intelligence, policy, guidance, and external influencing activities, and to establish a coordinated, future‑oriented approach for monitoring, interpreting, disseminating, and influencing emerging policy across relevant regions. External influencing priorities and annual objectives are aligned with CMC RA SLT and CMC RA Influences priorities and the company’s business needs. The role translates external developments into CMC RA strategies, frameworks, training, and organizational recommendations and actively bridges learning back to the broader department and functional business partners. The role also provides CMC RA Combination Product leadership for selected novel, ambiguous, or complex programs where CMC RA CP accountability is required and strategic consultation for other drug-device programs where CMC RA CP expertise supports early risk identification, mitigation planning, and efficient transition if a program evolves into a combination product. As a senior scientific leader, the role serves as a key advisor and mentor to less experienced colleagues and periodically communicates priorities, progress, and organizational impact to the department.

Responsibilities

You will be responsible for: Driving innovative CMC regulatory strategies and advance regulatory knowledge for novel, ambiguous, and complex combination products and other drug-device programs where regulatory expectations are evolving, inconsistently applied across regions, or lack clear precedent. Representing J&J through leadership or active participation in external regulatory, industry, trade association, benchmarking, external symposia, and policy‑shaping forums Partnering with regulatory intelligence and policy stakeholders to identify gaps and establish coordinated external influencing priorities aligned with CMC RA SLT, CMC RA Influences, and company business needs. Serving as the CMC RA Combination Product (CP) lead for selected novel, ambiguous, or complex programs Providing strategic consultation for other drug-device programs where CMC RA CP expertise can support early risk identification, regulatory strategy development, and transition to formal combination product programs if required. Serving as a recognized CMC RA subject matter expert for global combination product and drug-device regulatory frameworks, including situations where device-related regulatory requirements are undefined, ambiguous, evolving, or inconsistently applied across regions. Providing expert interpretation and strategic guidance to functional partners where regulatory precedent is limited, and serve as a key advisor and mentor to less experienced colleagues Actively bridging external and program learning back to the broader department and functional business partners. Mentoring colleagues and strengthen organizational capability in combination product and device‑related CMC regulatory strategy.

Qualifications / Requirements

A minimum of a Bachelor’s degree in biological, pharmaceutical, chemical, engineering, regulatory science, medical device, or other relevant scientific discipline is required. A minimum of 12 years of relevant experience in the pharmaceutical, biotechnology, medical device, or regulated healthcare industry; inclusive of post‑graduate education, is required. Significant experience in CMC Regulatory Affairs, Regulatory Affairs, medical device regulatory affairs, or a related regulated healthcare function is required. Demonstrated expertise in drug-device combination product regulatory strategy, including development and implementation of global CMC regulatory strategies for clinical, marketing, and lifecycle submissions is required. Demonstrated knowledge of global combination product and medical device regulatory requirements, including requirements relevant to medical device quality systems, device risk management, human factors/usability engineering, investigational devices, and device‑related submission content is required. Experience interpreting and applying evolving regulatory expectations for combined‑use programs, investigational device components, cross‑labeled, and/or one‑way labeled products is required. Demonstrated experience serving as the CMC Regulatory Affairs lead or key regulatory contributor, including development of CMC regulatory strategies, regulatory risk assessments, mitigation plans, Health Authority engagement strategies, and submission content approaches for complex combination product or combined‑use programs is required. Experience with device‑related regulatory submissions or submission content, such as IDEs, 510(k)s, PMAs, technical files to support CE marking, technical dossiers for Notified Body Opinions, EU Clinical Investigation Applications, or comparable global device regulatory submissions is required. Experience preparing for, leading, or providing strategic support for Health Authority interactions involving complex CMC, device, delivery system, or combination product issues is required. Demonstrated ability to influence senior stakeholders and cross‑functional teams in a global matrix environment, including stakeholders across CMC, clinical, quality, device/delivery system, supply‑chain, Global Regulatory Affairs, and business development/due diligence functions is required. Demonstrated ability to establish or improve frameworks, templates, decision tools, best practices, training materials, or governance approaches that improve consistency, capability, and decision‑making across programs is required. Strong scientific judgment, problem‑solving skills, negotiation skills, and written and verbal communication skills, with the ability to present and defend CMC regulatory strategies and recommendations to senior audiences is required. 5% domestic or international travel is required. Deep knowledge of global combination product, medical device, investigational device, and CMC regulatory requirements is preferred. Recognized expertise in combined‑use, cross‑labeled, and other complex drug‑device regulatory frameworks is preferred. Ability to influence senior leadership and drive alignment across functions, sectors, and external partners in a global matrix environment is preferred. Demonstrated ability to develop regulatory frameworks, governance approaches, and best practices that support consistency, scalability, and organizational learning is preferred. Demonstrated ability to mentor and develop technical and regulatory capability within CMC Regulatory Affairs is preferred.

Required and Preferred Skills

Required Skills: Consulting, Corporate Governance, Design Mindset, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Mentorship, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Scientific Research, Stakeholder Management, Strategic Thinking, Technical Writing

Preferred Skills: Consulting, Corporate Governance, Design Mindset, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Mentorship, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Scientific Research, Stakeholder Management, Strategic Thinking, Technical Writing

Base Pay

The anticipated base pay range for this position is : $168,000.00 - $290,950.00

Pay Transparency and Benefits

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

Equal Opportunity

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.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

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