Principal Scientist (Manager), Global Regulatory Affairs, CMC

Location: Onsite/hybrid role available in Beerse, Belgium; Leiden, Netherlands; Warsaw, Poland; and additional postings in the United States and Switzerland.

Annual base pay: €79,800–€137,770 in the primary posting location; €68,600–€119,600 in the Netherlands; PLN 205,000–354,200 in Poland.

Company

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

What you will do

• Develop and execute global CMC regulatory strategies for large molecules, biologics, vaccines, delivery devices, and cell and gene therapy products.
• Lead CMC regulatory activities across clinical development, commercialization, and post-marketing lifecycle management.
• Prepare and review regulatory dossiers and global submission plans for Health Authorities.
• Provide regulatory assessments of CMC changes and advise project teams on regulatory responses and interactions.
• Represent CMC Regulatory Affairs on cross-functional CMC, Value Chain, and Global Regulatory teams.
• Communicate critical compliance and registration issues to management and build effective relationships with Health Authorities.

Requirements

• BS/BA in biological, pharmaceutical, chemical, or engineering sciences.
• At least 8 years of relevant experience, including postgraduate education and/or pharmaceutical or healthcare industry experience.
• Experience with biologics and product development or lifecycle management for large molecules.
• Strong understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry.
• Strong verbal and written communication, technical writing, strategic thinking, and attention to detail.
• Ability to travel domestically and internationally up to 10%.

Nice to have

• MS, Ph.D., or Pharm.D. degree.
• Experience developing regulatory strategies and understanding product development.
• Knowledge of EU and FDA regulations.
• Experience in regulatory compliance, scientific research, consulting, coaching, and SME collaboration.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo.
• Annual performance bonus based on pay grade, location, and prior-year performance.
• Vacation, parental leave of at least 12 weeks, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Recognition awards and access to insurance plans subject to local eligibility and plan terms.