Senior Scientist, Product Lead – CMC Regulatory Affairs
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • Pennsylvania • United States
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Salary
💰 $109,000 - $174,800 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory filingsregulatory dossiersCMC documentationdrug developmentanalytical developmentmanufacturingbiological sciencespharmaceutical scienceschemical engineering
Soft Skills
communicationattention to detailcross-functional collaborationpresentation skillsdefense of regulatory strategycontinuous improvement
Certifications
BS in biological sciencesBS in pharmaceutical sciencesBS in chemical engineeringMS degreePh.D. degreePharm. D. degree