Senior Scientist, Product Lead Cmc Regulatory Affairs

J&J FAMILY OF COMPANIES

Titusville, New Jersey, United States of America
Base: $109,000.00 - $174,800.00; benefits: vacatio...
Hybrid
Cmc regulatory strategies
Global regulatory filings
Health authority responses
Johnson & Johnson is seeking a Senior Scientist, Product Lead in CMC Regulatory Affairs to contribute to global regulatory strategies and submissions. This role requires expertise in regulatory requirements and a solid understanding of the pharmaceutical industry, with a focus on collaboration across various teams

Job Summary

  • The Senior Scientist, Product Lead CMC Regulatory Affairs is a leading expert individual contributor responsible for major portions of complex regulatory submissions and conveying information on regulatory aspects to various teams.
  • Responsibilities include contributing to global CMC regulatory strategies, supporting global regulatory filings, preparing regulatory dossiers, and coordinating CMC country specific documents.
  • Employees are eligible for a comprehensive benefits package including retirement plans, vacation, sick time, holiday pay, parental leave, and volunteer leave.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Scientist, Product Lead in CMC Regulatory Affairs to contribute to global regulatory strategies and submissions. This role requires expertise in regulatory requirements and a solid understanding of the pharmaceutical industry, with a focus on collaboration across various teams.

Salary

Base: $109,000.00 - $174,800.00; 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

  • CMC regulatory strategies
  • global regulatory filings
  • Health Authority responses
  • scientific/technical expertise
  • product development globally

Nice-to-have

  • continuous improvement culture
  • model behavior
  • inclusive work environment
  • diversity and dignity

Key Requirements

  • BS degree with 6+ years experience
  • MS, PhD, or PharmD preferred
  • Demonstrated ability to communicate regulatory requirements
  • Experience interacting with Health Authorities

Work Rights

Not specified

Tailored Resume

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