Senior Scientist, Product Lead CMC Regulatory Affairs (Pharmaceuticals)

Location: Hybrid role based in Titusville, Raritan, or Spring House, New Jersey, or Horsham, Pennsylvania, United States

Salary: $109,000–$174,800 per year

Company

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

What you will do

• Drive scientific strategy and critical decision-making for pharmaceutical development using biology, pharmacology, biomarkers, human genetics, and clinical data.
• Develop global CMC regulatory strategies and dossier plans for development compounds and marketed products.
• Represent CMC Regulatory Affairs on CMC, core, and global regulatory teams.
• Prepare and coordinate regulatory dossiers, country-specific documents, Health Authority responses, and post-approval submissions.
• Assess CMC changes, support regulatory planning, and escalate issues affecting registration, compliance, and product lifecycle management.
• Provide CMC regulatory support during Health Authority inspections and contribute to continuous improvement initiatives.

Requirements

• Bachelor’s degree in biological, pharmaceutical, chemical, engineering, or a related scientific discipline.
• At least 4 years of related pharmaceutical or healthcare industry experience, including postgraduate education.
• Experience in drug development, analytical development, or manufacturing.
• Experience interacting with Health Authorities and working knowledge of global laws, regulations, and guidance.
• Ability to present and defend CMC regulatory strategies and communicate regulatory requirements across functions and organizations.
• Excellent verbal and written communication skills, strong attention to detail, and solid knowledge of biology, chemistry, and/or engineering relevant to pharmaceuticals.

Nice to have

• Master’s degree, PharmD, or Ph.D.
• Experience with NDA, BLA, MAA, IND, CTA, or post-approval variation submissions.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo and commitment to diversity and dignity.
• Participation in pension and 401(k) savings plans.
• Eligibility for a long-term incentive program.
• Paid vacation, sick time, holidays, parental, bereavement, caregiver, volunteer, and military spouse leave.