Senior Principal Scientist, CMC Regulatory Affairs – Combination Products

Johnson & Johnson

. Lead complex, novel, high-risk, or business-critical combination product programs as the CMC Regulatory Affairs lead .

Posted 10/23/2026full-timeUnited StatesSenior💰 $137,000 - $235,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading complex regulatory strategies for combination products and medical devices, with a strong understanding of global regulatory requirements and frameworks. Capable of providing technical leadership, mentoring, and strategic oversight across cross-functional teams to ensure compliance and successful product development.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Regulatory StrategiesCombination Product DevelopmentRegulatory Risk AssessmentRegulatory Affairs Certification (RAC)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Requirements InterpretationClinical Trial ApplicationsMarketing ApplicationsDesign Control ConceptsRisk Management PrinciplesQuality Management System PrinciplesLifecycle Management ActivitiesHealth Authority InteractionsNotified Body InteractionsSubmission Content Development

Soft Skills

Excellent Communication SkillsStrong Negotiation SkillsStakeholder ManagementStrategic Problem-SolvingInfluencing Decision-Making

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceCombination ProductRegulated Healthcare EnvironmentFDA Regulations21 CFR Part 4EU MDREmerging Regulatory TrendsIndustry Associations

About the role

Key responsibilities & impact

Lead complex, novel, high-risk, or business-critical combination product programs as the CMC Regulatory Affairs lead
Serve as a core member of combination product development teams and an ad hoc member of CMC, Value Chain, and Global Regulatory teams
Provide expert interpretation of global combination product and medical device regulatory requirements and evolving Health Authority expectations
Lead global regulatory strategies for clinical, marketing, and lifecycle management submissions involving combination products
Develop strategic options, regulatory risk assessments, mitigation plans, contingency planning, and recommendations affecting 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 design control deliverables
Lead regulatory assessments and strategic decisions for complex manufacturing, device, user interface, platform, and product changes
Lead regulatory strategies for Health Authority interactions, briefing books, scientific advice meetings, workshops, and responses
Represent or support CMC Regulatory Affairs in selected Health Authority interactions
Lead cross-functional initiatives involving 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, industry associations, standards-development activities, benchmarking initiatives, and regulatory policy discussions
Contribute to organizational positions on emerging regulatory topics and communicate external insights influencing regulatory strategies across programs and therapeutic areas
Support global development, registration, and lifecycle management of combination products

Requirements

What you’ll need

A minimum of a Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is 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, 21 CFR Part 4, QMSR, 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
Ability to leverage internal and external expertise to address complex regulatory issues and develop practical business solutions
Ability to provide guidance, coaching, and technical leadership to regulatory and cross-functional colleagues
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: advanced degree (Master’s, PharmD, Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline
Preferred: experience leading global regulatory strategies for complex pharmaceutical, biologic, medical device, and/or drug-device combination product programs
Preferred: experience with industry associations, trade organizations, standards-development initiatives, benchmarking consortia, or regulatory policy discussions
Preferred: demonstrated ability to mentor, coach, and develop regulatory and technical professionals
Preferred: ability to develop regulatory approaches for complex, novel, or evolving regulatory issues
Preferred: ability to evaluate emerging regulatory trends and translate insights into regulatory and business strategies
Preferred: ability to influence through scientific and regulatory expertise internally and externally
Preferred: Regulatory Affairs Certification (RAC)

Benefits

Comp & perks

Participation in the Company’s consolidated retirement plan (pension)
Savings plan (401(k))
Eligibility to participate in the Company’s long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year