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

Role fit

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 ComplianceDrug Development ExperienceBiological and Chemical Understanding

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentPharmaceutical Industry KnowledgeAnalytical DevelopmentManufacturing ExperienceHealth Authority InteractionRegulatory AssessmentNDA SubmissionBLA SubmissionMAA SubmissionIND Submission

Soft Skills

Excellent Communication SkillsAttention to DetailCross-Functional Collaboration

Certifications & Qualifications

Bachelor’s Degree in Biological SciencesBachelor’s Degree in Pharmaceutical SciencesBachelor’s Degree in Chemical Engineering

Industry Keywords

Pharmaceutical IndustryRegulatory ComplianceHealth Authority RegulationsCMC DocumentationProduct 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 Health Authority submission
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, and post-approval variation submissions
Assist with regulatory assessments of CMC changes
Escalate issues affecting registration, regulatory compliance, and product lifecycle management
Execute or develop contingency plans for registration, compliance, and lifecycle issues
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 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 communicate regulatory requirements to stakeholders cross-functionally and cross-company
Excellent verbal and written communication skills
Strong attention to detail
Advanced degree (Master’s, PharmD, Ph.D.) preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
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 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 accommodations for applicants with disabilities