Senior Principal Scientist, CMC Regulatory Affairs – Combination Products

Johnson & Johnson

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

Posted 10/23/2026full-timeBeerse • BelgiumSenior💰 €96,000 - €165,025 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading CMC Regulatory Affairs for combination products, with a strong focus on global regulatory strategies, risk management, and Health Authority interactions. Proven ability to provide technical leadership and influence decisions across functions in a complex regulatory environment.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Regulatory StrategiesDrug-Device Combination ProductsHealth Authority InteractionsRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Risk AssessmentsLifecycle ManagementQuality Management SystemsDesign ControlHuman Factors EngineeringRegulatory SubmissionsTechnical Dossier ReviewRegulatory Process ImprovementsStrategic RecommendationsContingency Planning

Soft Skills

Excellent Communication SkillsNegotiation SkillsStakeholder ManagementStrategic Problem-SolvingMentoring Ability

Certifications & Qualifications

RAC Certification

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceCombination ProductFDA RegulationsEU MDR21 CFR Part 4Notified Body InteractionsRegulated Healthcare EnvironmentIndustry Standards

About the role

Key responsibilities & impact

Lead CMC Regulatory Affairs for complex, novel, high-risk, or business-critical combination product programs
Serve on combination product development teams and potentially CMC, Value Chain, and Global Regulatory Teams
Interpret global combination product and medical device regulatory requirements and Health Authority expectations
Develop global regulatory strategies for clinical, marketing, and lifecycle management submissions
Conduct regulatory risk assessments, mitigation plans, contingency planning, and strategic recommendations
Review device and combination product submission content, Notified Body technical dossiers, and design control deliverables
Lead regulatory assessments 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 improvements, guidance implementation, standards development, training, and capability building
Provide technical leadership, mentoring, and coaching
Represent Johnson & Johnson Innovative Medicine in industry associations, standards activities, working groups, benchmarking, and regulatory policy discussions
Contribute to organizational positions and communicate external insights affecting regulatory strategies

Requirements

What you’ll need

Minimum of a Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline
Minimum of 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development
Experience in a 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 systems, lifecycle management, and related regulatory requirements
Knowledge of global regulatory requirements for drug-device combination products and medical devices, including FDA combination product regulations, 21 CFR Part 4, QMSR, EU MDR, and related 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 decisions across functions and organizational boundaries without direct authority in 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, experience leading global regulatory strategies, industry/standards/policy experience, mentoring/coaching ability, emerging-trend evaluation, external influence, and RAC certification

Benefits

Comp & perks

Annual bonus with set target depending on pay grade/location, based on employee and company performance
Vacation days
Parental leave for a minimum of 12 weeks
Bereavement leave
Caregiver leave
Volunteer leave
Well-being reimbursement
Financial, physical, and mental health programs
Service anniversary and recognition awards
Insurance plans for employees and eligible dependents in some locations
Sales commissions where applicable