Johnson & Johnson is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs responsible for overseeing complex regulatory submissions and contributing to global CMC regulatory strategies. The ideal candidate will have a strong background in regulatory science, communication skills, and a solid understanding of the pharmaceutical industry
Job Summary
The Senior Scientist, Product Lead CMC Regulatory Affairs is a leading expert individual contributor and works independently to own major portions of complex regulatory submissions.
You will be responsible for contributing to the development of global CMC regulatory strategies and dossier plans according to scientific/risk-based principles.
Johnson & Johnson is an Equal Opportunity Employer and is committed to providing an inclusive work environment.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs responsible for overseeing complex regulatory submissions and contributing to global CMC regulatory strategies. The ideal candidate will have a strong background in regulatory science, communication skills, and a solid understanding of the pharmaceutical industry.
Salary
Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation –120 hours per calendar year, Sick time - 40 hours per calendar year, Holiday pay –13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave – 480 hours, Bereavement Leave – 240 hours for an immediate family member, Caregiver Leave – 80 hours, Volunteer Leave – 32 hours, Military Spouse Time-Off – 80 hours
Skills & Requirements
Must-have
Global CMC regulatory strategies
Regulatory CMC Lead
Global regulatory filings
Health Authority responses
Continuous improvement culture
Nice-to-have
Scientific/risk-based principles
Model behavior
Cross-functional communication
Attention to detail
Key Requirements
BS in biological, pharmaceutical, chemical or engineering sciences
Minimum 6+ years of experience
MS, Ph.D., or Pharm. D. degree preferred
Demonstrated ability to communicate regulatory requirements