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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 .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CMC Regulatory Affairs, including the preparation of regulatory dossiers and compliance with global Health Authority regulations. Strong ability to integrate scientific strategy with regulatory requirements and communicate effectively with cross-functional teams.
Highest-signal resume keywords
CMC Regulatory AffairsRegulatory Dossier PreparationGlobal Health Authority RegulationsDrug Development ExperienceCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Biological SciencesPharmaceutical SciencesChemical EngineeringAnalytical DevelopmentManufacturing ExperienceRegulatory StrategyRisk-Based PrinciplesNDA/BLA/MAA/IND/CTA DossiersCMC Document ManagementHealth Authority Interactions
Soft Skills
Attention to DetailVerbal CommunicationWritten CommunicationCross-Functional CollaborationResults-Driven Mindset
Industry Keywords
Pharmaceutical IndustryRegulatory ComplianceContinuous ImprovementHealth Authority SubmissionsLifecycle 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 Health Authority submission under supervision
- Coordinate, compile, and manage country-specific CMC documents for global submissions
- Assist with CMC Health Authority responses
- Participate in selected CMC Regulatory Affairs/Global Regulatory Affairs initiatives
- Drive continuous improvement and compliance with company standards and regulatory requirements
- Communicate critical issues to Management
- Align CMC regulatory strategy with global Regulatory Affairs, therapeutic area, commercial, regional, and QTPP strategies
- Provide input to NDA/BLA/MAA/IND/CTA and post-approval variation dossiers
- Assess CMC changes for regulatory planning and implementation
- Escalate registration, compliance, and lifecycle-management issues to CMC Regulatory Affairs Management
- Execute or develop contingency plans
- Provide CMC Regulatory support to Health Authority inspections
Requirements
What you’ll need- Minimum Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or a related scientific discipline
- 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 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 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
- Programs for financial, physical and mental health
- Service anniversary and recognition awards
- Insurance plans for employees and, in some locations, eligible dependents