Senior Scientist Product Lead CMC RA (Synthetics, New Modalities)

Location: East Coast USA locations, Beerse, Belgium, or Warsaw, Poland. Additional listed locations include Horsham, Raritan, Spring House, and Titusville in the United States.

Salary: $109,000–$174,800 per year.

Company

Johnson & Johnson MedTech develops healthcare and innovative medicine solutions focused on preventing, treating, and curing complex diseases.

What you will do

• Develop global CMC regulatory strategies and dossier plans using scientific and risk-based principles.
• 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 and coordinate country-specific documents for Health Authority submissions.
• Develop CMC Health Authority responses and provide regulatory support during inspections.
• Assess CMC changes, escalate issues, and support contingency planning for registration, compliance, and lifecycle management.

Requirements

• BS degree in biological, pharmaceutical, chemical, or engineering sciences, with generally at least 6 years of relevant experience including postgraduate education or pharmaceutical or healthcare industry experience.
• Strong understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry.
• Experience in drug development, analytical development, or manufacturing.
• Knowledge of global Health Authority laws, regulations, and guidance.
• Ability to communicate regulatory requirements and present or defend CMC regulatory strategies to cross-functional teams.
• Strong verbal and written communication skills, attention to detail, and experience interacting with Health Authorities under senior supervision.

Nice to have

• MS, Ph.D., or Pharm.D. degree.
• Experience with synthetic products or new modalities.

Culture & Benefits

• Inclusive work environment centered on individual dignity, diversity, and merit.
• Participation in pension and 401(k) savings plans, subject to plan terms.
• Eligibility for the long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.