Principal Scientist, CMC Regulatory Affairs

Location: Warsaw, Masovian, Poland

Base pay: zł205,000.00–zł354,200.00

Company

Johnson & Johnson MedTech develops healthcare solutions and medical technologies across Innovative Medicine and MedTech.

What you will do

• Act as the CMC Regulatory Lead on CMC and Value Chain Teams, providing regulatory expertise for global product development.
• Develop and execute global CMC regulatory strategies for synthetic drugs and delivery devices across pre- and post-approval activities.
• Prepare and review regulatory dossiers for global submissions throughout the product lifecycle.
• Develop regulatory strategies and responses for Health Authorities and communicate critical issues to management.
• Assess CMC changes, develop contingency plans, and support registration, compliance, and lifecycle management.
• Participate in Global Regulatory Teams, due diligence, licensing evaluations, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in biological, pharmaceutical, chemical, or engineering sciences with generally at least 8 years of relevant experience, including postgraduate education or pharmaceutical and healthcare industry experience.
• Strong understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry.
• Experience developing regulatory strategies and applying product development expertise to global regulatory planning.
• Knowledge of global Health Authority laws, regulations, guidance, and submission routes.
• Experience interacting with Health Authorities under the supervision of senior CMC Regulatory Affairs staff.
• Strong attention to detail and high-level verbal and written communication skills, including cross-functional and cross-company collaboration.

Nice to have

• MS, Ph.D., or Pharm.D. degree.
• Understanding of competitors and early- and late-stage development activities in the relevant area.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and recognition.
• Annual bonus with a target based on pay grade and location.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, and recognition programs subject to plan terms.