Senior Principal Scientist, CMC Regulatory Affairs – Combination Products

Johnson & Johnson

. Lead CMC Regulatory Affairs Combination Product activities for complex, novel, high-risk, or business-critical 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 assessments, and Health Authority interactions. Proven ability to mentor teams and influence decision-making in complex regulatory environments.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Regulatory StrategiesCombination Product DevelopmentHealth Authority InteractionsRegulatory Risk Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Requirements InterpretationDesign ControlRisk ManagementQuality Management SystemsLifecycle ManagementSubmission Content DevelopmentTechnical Dossier ReviewRegulatory Submission SupportComplex Regulatory Strategy LeadershipStakeholder Management

Soft Skills

Excellent Communication SkillsStrong Negotiation SkillsStrategic Problem-SolvingCoaching and MentoringInfluencing Without Authority

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceCombination ProductFDA Regulations21 CFR Part 4EU MDRNotified Body InteractionsEmerging Regulatory TrendsStandards Development

About the role

Key responsibilities & impact

Lead CMC Regulatory Affairs Combination Product activities for complex, novel, high-risk, or business-critical programs
Serve as a core member of combination product development teams and an ad hoc member of 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 cross-functional initiatives involving process improvements, guidance implementation, standards development, training, and organizational capability building
Mentor and coach 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

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 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 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 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
Ability to influence decision-making 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
Willingness to travel 10% domestically or internationally
Preferred: Regulatory Affairs Certification (RAC) and experience with global regulatory strategies, industry associations, standards development, mentoring, emerging regulatory trends, and complex regulatory issues

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 awards
Recognition awards
Insurance plans for employees and eligible dependents in some locations