New · posted Oct 23
Johnson & Johnson · Pharmaceuticals
Senior Principal Scientist, CMC Regulatory Affairs - Combination Products
- Raritan, NJ +3 more
- Hybrid
- Full-time
- Senior & Principal
Closes Nov 6, 2026 · 15 days left
The role
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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):
Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA
The Senior Principal Scientist, CMC Regulatory Affairs - Combination Products role is a senior scientific and regulatory subject matter expert responsible for leading complex combination product regulatory strategies, programs, projects, and processes spanning multiple related technical and regulatory areas. This role may support pre-approval and post-approval programs, synthetic products or biologic products, and products in any therapeutic area.
The Senior Principal Scientist may serve as a core member of the combination product development team and ad hoc member of the CMC (Chemistry, Manufacturing, and Controls) team, Value Chain team for post-approval programs, and Global Regulatory Team. This role will also support the successful development, registration, and lifecycle management of combination products globally.
The role will apply comprehensive scientific, technical, and regulatory knowledge to address complex regulatory challenges where requirements may be evolving and precedent may be limited. Provide technical leadership, mentoring, and coaching to regulatory and cross-functional colleagues and contributes to development of organizational capability.
What you need
Education
- A minimum of a Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is required. Advanced degree (Master’s, PharmD, Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred.
Required:
- A minimum of 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
- Experience in the pharmaceutical, biotechnology, medical device, combination product or other regulated healthcare environment.
- Understanding of drug-device combination product development processes, including design control concepts, risk management principles, human factors/usability engineering principles, quality management system principles, lifecycle management activities, and associated regulatory requirements.
- Knowledge of global regulatory requirements and frameworks applicable to drug-device combination products and medical devices, including FDA combination product regulations and guidance documents (e.g., 21 CFR Part 4), Quality Management System Regulation (QMSR), EU Medical Device Regulation (EU MDR), and related global guidance documents.
- Experience supporting development, registration, or lifecycle management of pharmaceutical, biologic, medical device, and/or drug-device combination products.
- Experience supporting global regulatory submissions, Health Authority interactions, Notified Body interactions, and device-related CMC submission content.
- Demonstrated ability to lead complex regulatory strategies, programs, projects, or processes spanning multiple related technical or functional areas.
- The ability to leverage internal and external expertise to address complex regulatory issues and develop practical business solutions.
- The ability to provide guidance, coaching, and technical leadership to regulatory and cross-functional colleagues.
- The ability to influence decision-making across functions and organizational boundaries without direct authority and lead activities across a global, matrix organization.
- Excellent written and verbal communication skills.
- Strong negotiation and stakeholder management skills.
- Strong strategic problem-solving skills.
- 10% domestic or international travel
Preferred:
- Experience leading global regulatory strategies for complex pharmaceutical, biologic, medical device, and/or drug-device combination product programs.
- Experience participating in or leading activities involving industry associations, trade organizations, standards-development initiatives, benchmarking consortia, or regulatory policy discussions.
- Demonstrated ability to mentor, coach, and develop regulatory and technical professionals.
- Ability to develop regulatory approaches for complex, novel, or evolving regulatory issues.
- Ability to evaluate emerging regulatory trends and translate insights into regulatory and business strategies.
- Ability to influence through scientific and regulatory expertise both internally and externally.
- Regulatory Affairs Certification (RAC).
Preferred Skillsnice to have
Consulting, Corporate Governance, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Mentorship, Public Policies, Regulatory Compliance, Regulatory Development, Regulatory Environment, Scientific Research, Strategic Thinking, Subject Matter Experts (SME) Collaboration, Tactical Planning, Technical Credibility, Technical Writing
Pay and benefits
$137,000 – $235,750 a year
Employer providedThe anticipated base pay range for this position is
$137,000.00 - $235,750.00
Pension and 401(k) savings plan
Long-term incentive program
Vacation (120 hours per year)
13 paid holidays
Parental leave (480 hours)
Sick time and caregiver leave
Where you'll work
Raritan, NJ +3 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Titusville, NJ · Spring House, PA · Horsham, PA
More jobs in Raritan, NJ +3 moreWorking conditions
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
From the posting
About Johnson & Johnson
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
- United States - Requisition Number: R-105727
- Switzerland - Requisition Number: R-106762
- Belgium, Poland - Requisition Number: R-106770
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
This individual will provide expert interpretation of global combination product and medical device regulatory requirements and advise multiple project teams and management on complex, high-risk, novel, or precedent-setting regulatory issues. Leverage internal medical device regulatory expertise across Johnson & Johnson Innovative Medicine and Johnson & Johnson MedTech as needed to support development of robust and globally aligned regulatory strategies.
The Senior Principal Scientist will represent Johnson & Johnson in external regulatory, industry, and scientific forums related to combination products and medical devices. Through participation in industry associations, benchmarking activities, working groups, standards-development initiatives, and regulatory policy discussions, the individual will contribute to organizational understanding of emerging regulatory expectations and influences regulatory strategies across multiple programs, therapeutic areas, and product modalities.
Principal Responsibilities:
- Serve as CMC Regulatory Affairs (RA) Combination Product lead for complex, novel, high-risk, or business-critical combination product programs. Serve as a core member of one or more combination product development teams and may serve as an ad hoc member of the CMC team, Value Chain team for post-approval programs, and Global Regulatory Team. Provide expert interpretation of global combination product and medical device regulatory requirements and evolving Health Authority expectations for drug-device combination products and related device constituent parts used in the preparation or administration of drugs.
- Lead development of global regulatory strategies for clinical, marketing, and lifecycle management submissions involving combination products, including development of strategic options, regulatory risk assessments, mitigation plans, contingency planning, and recommendations with direct impact on program and business outcomes.
- Provide strategic oversight and expert review of device and combination product-specific submission content for clinical trial applications, marketing applications, Notified Body technical dossiers, and applicable design control deliverables. Establish regulatory approaches for complex submission content where requirements are evolving, interpretation is required, or precedent is limited.
- Lead regulatory assessments and strategic decision-making for complex manufacturing, device, user interface, platform, and product changes with potential global, cross-program, or significant lifecycle impact.
- Lead development of regulatory strategies for significant Health Authority interactions, briefing books, scientific advice meetings, workshops, and responses related to complex combination product regulatory questions. Represent or support representation of CMC RA during selected Health Authority interactions involving combination product regulatory strategy.
- Lead cross-functional initiatives related to regulatory process improvements, guidance implementation, standards development, training, and organizational capability building. Provide technical leadership, mentoring, and coaching to regulatory and cross-functional colleagues.
- Represent Johnson & Johnson Innovative Medicine in external combination product and medical device regulatory activities, including industry associations, trade organizations, standards-development activities, working groups, benchmarking initiatives, and regulatory policy discussions. Contribute to development of organizational positions on emerging regulatory topics, support alignment across industry and regulatory stakeholders, and communicate external insights that influence regulatory strategies across multiple programs, therapeutic areas, and product modalities.
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
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
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 24% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Senior & Principal roles in the US7 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $137,000 | — | $235,750 |
| All US (middle half) | $120,000 | $150,500 | $193,250 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 87 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- GMP and compliance2
- Documentation and SOPs2
- Regulatory submissions2
- Quality systems and risk2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Johnson & Johnson on Regulatory Jobs
- 39
- Open roles
- 38
- Distinct roles
- 19
- Locations
By discipline
- Quality24 62%
- Regulatory13 33%
- Compliance & Safety2 5%
By level
- Senior & Principal13 33%
- Associate & Specialist12 31%
- Manager10 26%
More roles at Johnson & Johnson
- View role
Sr. Quality Engineer
Danvers, MA +1 moreSenior & PrincipalMedical Devices$79K–$128K
- View role
Complaint Quality Approver
Gurabo, PRSenior & PrincipalPharmaceuticalsSalary not listed
- View role
Senior Regulatory Affairs Specialist
West Chester, PASenior & PrincipalMedical Devices$109K–$175K
- View role
Senior Quality Engineer, QMS
Athens, GASenior & PrincipalPharmaceuticals$79K–$128K
Similar Regulatory CMC roles elsewhere
- View role
Senior Scientist, Regulatory Affairs - CMC - Synthetic Moieties of ADCs and Bioconjugates
MerckNorth Wales, PA +1 more · HybridSenior & PrincipalPharmaceuticals$117K–$184K
- View role
Advisor/Sr. Advisor - Regulatory CMC
Eli LillyBoston, MA +1 more · HybridSenior & PrincipalPharmaceuticals$168K–$268K
- View role
Regulatory Site Officer
SanofiSwiftwater, PA · HybridSenior & PrincipalPharmaceuticals$90K–$130K
- View role
Regulatory Affairs Consultant - CMC Biologics / Plasma Products
ParexelRemote, USSenior & PrincipalPharmaceuticalsSalary not listed
Senior Principal Scientist, CMC Regulatory Affairs - Combination Products at Johnson & Johnson
Applications close November 6. $137K–$236K a year, employer provided.