Senior Scientist, Product Lead CMC Regulatory Affairs (Synthetics, New Modalities)

Location: Hybrid role based in Beerse, Belgium or Warsaw, Poland

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

Company

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

What you will do

• Develop global CMC regulatory strategies and dossier plans for development compounds and potentially marketed products.
• Provide CMC regulatory expertise on CMC Core Teams and Global Regulatory Teams.
• Prepare and coordinate regulatory dossiers, country-specific documentation, and health authority responses.
• Assess CMC changes and support regulatory planning, implementation, registration, and product lifecycle management.
• Communicate regulatory requirements and critical issues to cross-functional stakeholders and management.
• Support health authority inspections and continuous improvement of CMC regulatory processes.

Requirements

• Bachelor’s degree in biological, pharmaceutical, chemical, engineering, or a related scientific discipline; an advanced degree is preferred.
• At least 4 years of related pharmaceutical or healthcare industry experience, including postgraduate education.
• Solid understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry.
• Experience in drug development, analytical development, or manufacturing.
• Experience interacting with health authorities and working knowledge of global health authority laws, regulations, and guidance.
• Strong communication, presentation, technical writing, analytical reasoning, and attention-to-detail skills.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and individual contribution.
• Annual bonus with a target based on pay grade 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.
• Insurance plans and service anniversary and recognition awards, subject to applicable plan terms.