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

Location: Beerse, Belgium; Warsaw, Poland; or East Coast USA

Salary: €72,500–€115,230 annually in the primary posting location; Poland: PLN 163,000–262,200 annually.

Company

Johnson & Johnson develops healthcare, Innovative Medicine, and MedTech solutions focused on preventing and treating complex diseases.

What you will do

• Contribute to global CMC regulatory strategies and dossier plans based on scientific and risk-based principles.
• Support CMC regulatory leadership on cross-functional CMC, Global Regulatory, and project teams.
• Prepare and support global regulatory filings for development compounds and potentially marketed products.
• Coordinate country-specific CMC documents for global submissions and assist with health authority responses.
• Assess CMC changes and support regulatory planning, implementation, inspections, and lifecycle management.
• Escalate critical registration and compliance issues and contribute to contingency planning.

Requirements

• Bachelor’s degree in biological, pharmaceutical, chemical, or engineering sciences, with generally 6+ years of relevant experience including postgraduate education or pharmaceutical and healthcare industry experience.
• Working knowledge of global health authority laws, regulations, and guidance.
• Experience in drug development, analytical development, or manufacturing.
• Solid understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry.
• Ability to communicate regulatory requirements and present regulatory strategies to cross-functional project teams.
• Strong written and verbal communication skills, attention to detail, and experience interacting with health authorities under supervision.

Nice to have

• MS, Ph.D., or Pharm.D. degree.

Culture & Benefits

• Inclusive work environment focused on individual contribution, diversity, and dignity.
• Annual performance-based bonus or sales commissions, depending on role and location.
• Vacation, parental leave of at least 12 weeks, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Recognition awards and access to insurance plans subject to local eligibility and plan terms.