Senior Principal Scientist, CMC Regulatory Affairs – Combination Products

Johnson & Johnson

. Serve as CMC Regulatory Affairs Combination Product lead for complex, novel, high-risk, or business-critical programs .

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 CMC Regulatory Affairs for combination products, with a strong focus on global regulatory strategies, risk assessments, and Health Authority interactions. Proven ability to lead complex regulatory processes and provide technical leadership across cross-functional teams.

Highest-signal resume keywords

Regulatory Affairs ExperienceCombination Product DevelopmentGlobal Regulatory SubmissionsRisk ManagementStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentSubmission Content ReviewDesign ControlQuality Management System PrinciplesLifecycle ManagementFDA Combination Product RegulationsEU MDR ComplianceTechnical Dossier PreparationRisk AssessmentHuman Factors Engineering

Soft Skills

Excellent Communication SkillsNegotiation SkillsStrategic Problem-SolvingCoaching and MentoringInfluencing Without Authority

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceRegulated Healthcare EnvironmentHealth Authority InteractionsNotified Body InteractionsEmerging Regulatory TopicsStandards DevelopmentOrganizational Capability InitiativesCross-Functional Collaboration

About the role

Key responsibilities & impact

Serve as CMC Regulatory Affairs Combination Product lead for complex, novel, high-risk, or business-critical programs
Serve on combination product development teams and, as needed, CMC, Value Chain, and Global Regulatory Teams
Interpret global combination product and medical device regulatory requirements and evolving Health Authority expectations
Lead global regulatory strategies for clinical, marketing, and lifecycle management submissions
Develop strategic options, regulatory risk assessments, mitigation plans, contingency plans, and recommendations
Provide strategic oversight and expert review of device and combination product submission content, Notified Body technical dossiers, and design control deliverables
Lead regulatory assessments and strategic decisions for complex manufacturing, device, user interface, platform, and product changes
Develop 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 regulatory process improvement, guidance implementation, standards development, training, and organizational capability initiatives
Provide technical leadership, mentoring, and coaching to regulatory and cross-functional colleagues
Represent Johnson & Johnson Innovative Medicine in external regulatory, industry, standards-development, benchmarking, and policy activities
Contribute to organizational positions on emerging regulatory topics and communicate external insights influencing regulatory strategies

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
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, risk management, human factors/usability engineering, quality management system principles, lifecycle management, and associated regulatory requirements
Knowledge of global regulatory requirements and frameworks for 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
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
Ability to lead complex regulatory strategies, programs, projects, or processes across multiple 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
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
Ability to travel 10% domestically or internationally

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (Colorado: 48 hours; Washington: 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 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
Hybrid work arrangement