Hybrid Senior Scientist, Product Lead – CMC Regulatory Affairs

at Johnson & Johnson

• Job title: Senior Scientist, Product Lead – CMC Regulatory Affairs
• Job type: Full Time
• Experience level: Senior
• Salary: $109,000 - $174,800 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Titusville, United States

About the role

• Senior Scientist managing CMC Regulatory Affairs for healthcare innovation at Johnson & Johnson. Developing regulatory strategies and preparing submissions for Health Authorities.

Responsibilities

• Contributing to the development of global CMC regulatory strategies and dossier plans
• May participate as the Regulatory CMC Lead on CMC Teams
• Supporting global regulatory filings for development compounds and marketed products
• Preparing regulatory dossiers for submission to Health Authorities under supervision
• Coordinating, compiling, and managing CMC country specific documents
• Assisting in developing and preparing CMC Health Authority responses as needed
• Driving a culture of continuous improvement to ensure compliance with Johnson and Johnson standards

Requirements

• BS in biological, pharmaceutical, chemical or engineering sciences
• Generally a minimum of 6+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience
• An MS, Ph.D., or Pharm. D. degree preferred
• Demonstrated ability to communicate regulatory requirements is required
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is preferred
• Prior drug development, analytical development, or manufacturing experience preferred
• Strong attention to detail with high-level verbal and written communication skills preferred
• Communicates cross-functionally and cross-company
• Presents and defends CMC management-approved regulatory strategy and opinion to project teams preferred
• Experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff preferred
• Working knowledge of global HA laws, regulations and guidances preferred

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year