Senior Scientist, Product Lead – CMC Regulatory Affairs

Johnson & Johnson

. Drive scientific strategy and critical decision-making through integration of disease biology, pharmacology, biomarkers, human genetics, and clinical data .

Posted 9/23/2026full-timeBeerse • BelgiumSenior💰 €72,500 - €115,230 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC Regulatory Affairs, including the preparation of regulatory dossiers for NDA, BLA, MAA, IND, and CTA submissions. Possesses strong knowledge of global Health Authority regulations and the ability to communicate complex regulatory strategies effectively across teams.

Highest-signal resume keywords

CMC Regulatory AffairsRegulatory Dossier PreparationGlobal Health Authority RegulationsPharmaceutical Industry ExperienceBiological and Chemical Understanding

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Dossier PreparationCMC Regulatory StrategyPharmaceutical DevelopmentAnalytical DevelopmentManufacturing ExperienceRegulatory ComplianceHealth Authority InteractionsRisk-Based PrinciplesBiomarkers KnowledgeHuman Genetics Understanding

Soft Skills

Excellent Communication SkillsAttention to DetailCross-Functional CollaborationResults-Driven MindsetModel Behavior Leadership

Industry Keywords

NDABLAMAAINDCTAHealth Authority InspectionsRegulatory FilingsCMC DocumentsContinuous ImprovementProduct Lifecycle Management

About the role

Key responsibilities & impact

Drive scientific strategy and critical decision-making through integration of disease biology, pharmacology, biomarkers, human genetics, and clinical data
Contribute to global CMC regulatory strategies and dossier plans using scientific/risk-based principles
Participate as Regulatory CMC Lead on CMC Teams and represent CMC Regulatory Affairs on CMC Core Teams and Global Regulatory Teams
Support global regulatory filings for development compounds and potentially marketed products
Prepare regulatory dossiers for submission to Health Authorities under supervision
Coordinate, compile, and manage country-specific CMC documents for global submissions
Assist in developing and preparing CMC Health Authority responses
Participate in selected CMC Regulatory Affairs/Global Regulatory Affairs initiatives
Drive continuous improvement and ensure compliance with company standards and regulatory requirements
Communicate critical issues to Management
Align CMC regulatory strategy with global Regulatory Affairs, therapeutic area, commercial, regional functions, and QTPP strategies
Partner with Therapeutic Area Regulatory Affairs and senior CMC Regulatory Affairs personnel
Prepare dossiers for NDA, BLA, MAA, IND, CTA, and post-approval variation submissions
Provide regulatory assessments of CMC changes
Escalate issues affecting registration, regulatory compliance, and product lifecycle management
Execute or develop contingency plans
Provide CMC Regulatory support to Health Authority inspections

Requirements

What you’ll need

A minimum of a Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or a related scientific discipline is required
A minimum of 4 years of related pharmaceutical or health care industry experience, inclusive of post graduate education
Solid understanding of biology, chemistry and/or engineering relevant to the pharmaceutical industry
Prior drug development, analytical development, or manufacturing experience
Experience interacting with Health Authorities independently or under the supervision of CMC Regulatory Affairs staff
Working knowledge of global Health Authority laws, regulations and guidances
Ability to present and defend CMC management-approved regulatory strategy and opinion to project teams
Ability to demonstrate model behavior that understands priorities and encourages others to drive for results
Ability to communicate regulatory requirements to stakeholders cross-functionally and cross-company
Excellent verbal and written communication skills
Strong attention to detail

Benefits

Comp & perks

Annual bonus with set target (% of pay) depending on pay grade / location
Vacation days
Parental leave for a minimum of 12 weeks
Bereavement leave
Caregiver leave
Volunteer leave
Well-being reimbursement
Programs for financial, physical and mental health
Service anniversary and recognition awards
Several insurance plans for employees and, in some locations, eligible dependents
Sales commissions may be offered