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-timeUnited StatesSenior💰 $109,000 - $174,800 per yearWebsite

Core Competencies

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Core Competencies

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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

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Hard Skills

Biological SciencesPharmaceutical SciencesChemical EngineeringAnalytical DevelopmentManufacturing ExperienceRegulatory StrategyRisk-Based PrinciplesNDA/BLA/MAA/IND/CTA SubmissionsAttention to DetailHealth Authority Inspections

Soft Skills

Verbal CommunicationWritten CommunicationCross-Functional Collaboration

Industry Keywords

Pharmaceutical IndustryRegulatory ComplianceProduct Lifecycle ManagementCMC DocumentationTherapeutic Area Strategies

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
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, and QTPP strategies
Provide input to dossiers for NDA/BLA/MAA/IND/CTA submissions and post-approval variations
Assist with regulatory assessments of CMC changes
Escalate issues affecting registration, compliance, and product lifecycle management
Assist with contingency plans for registration, compliance, and lifecycle issues
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 communicate regulatory requirements to stakeholders cross-functionally and cross-company
Excellent verbal and written communication skills
Strong attention to detail

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
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 the 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
Inclusive interview process and accommodation support