Principal Scientist, Global Regulatory Affairs, CMC

Johnson & Johnson

Principal Scientist leading global CMC regulatory strategies for Johnson & Johnson’s innovative medicines. Developing dossiers, guiding health-authority interactions, and supporting biologics throughout product lifecycles.

Posted 8/5/2026full-timeHorsham • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $117,000 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing and executing global CMC regulatory strategies for large-molecule, vaccine, cell and gene therapy products, ensuring compliance with EU and FDA regulations. Strong communication skills facilitate effective collaboration with health authorities and cross-functional teams throughout the product lifecycle.

Highest-signal resume keywords

Regulatory CMC Strategy DevelopmentHealth Authority Submission PreparationBiologics Product DevelopmentEU and FDA Regulatory KnowledgeLifecycle Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Dossier PreparationCMC Regulatory StrategyBiologics ExperienceProduct DevelopmentRegulatory PlanningCompliance ManagementPharmaceutical Industry KnowledgeAttention to DetailGlobal Submission PlanningHealth Authority Interaction

Soft Skills

High-Level Communication SkillsCross-Functional Team Collaboration

Certifications & Qualifications

BS/BA in Biological SciencesMS, Ph.D., or Pharm.D. Preferred

Industry Keywords

Pharmaceutical IndustryRegulatory AffairsLarge MoleculesVaccine DevelopmentCell and Gene TherapyDelivery-Device ProductsContinuous ImprovementGlobal Regulatory TeamsTherapeutic Area Regulatory AffairsLifecycle Management Issues

About the role

Key responsibilities & impact

Participate as the Regulatory CMC Lead on CMC/Value Chain Teams and represent CMC Regulatory Affairs
Provide regulatory expertise and input to team recommendations for global product development
Participate on Global Regulatory Teams and develop global submission plans
Develop and execute global CMC regulatory strategies for large-molecule, vaccine, cell and gene therapy, and delivery-device products
Lead preparation of regulatory dossiers for Health Authority submissions
Develop regulatory CMC strategies for Health Authority responses and interactions
Participate in CMC RA / Global Regulatory Affairs initiatives
Drive continuous improvement and compliance with company standards and regulatory requirements
Communicate critical issues to management and represent CMC RA on cross-functional teams
Serve as a SPOC/SME on internal and external teams
Ensure product regulatory strategies meet global requirements throughout the product lifecycle
Maintain connectivity with the overall global regulatory strategy through partnership with Therapeutic Area Regulatory Affairs
Escalate registration, compliance, and lifecycle-management issues and develop contingency plans
Communicate with health authorities and maintain positive professional relationships
Review CMC regulatory dossiers throughout the product lifecycle
Assess CMC changes and execute regulatory planning and implementation

Requirements

What you’ll need

BS/BA in biological, pharmaceutical, chemical, or engineering sciences required, with 8+ years of experience inclusive of postgraduate education and/or pharmaceutical or healthcare industry experience or equivalent
Solid understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry
Experience in biologics and product development/lifecycle management of large molecules
Experience developing regulatory strategies and understanding product development preferred
Knowledge of EU and FDA regulations preferred
High-level verbal and written communication skills
Strong attention to detail
Ability to potentially travel up to 10% domestically and/or internationally
MS, Ph.D., or Pharm.D. preferred

Benefits

Comp & perks

Retirement plan (pension)
401(k) savings plan
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