Product Manager for MACI at Vericel leading brand execution and promotional initiatives. Collaborating with cross - functional teams in a regulated healthcare environment.
About the role
- Senior Scientist leading CMC Regulatory Affairs for Johnson & Johnson. Responsibilities include regulatory strategy development and global submissions management in a complex healthcare landscape.
Responsibilities
- Contributing to the development of global CMC regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other Global CMC Regulatory Affairs (CMC RA) personnel.
- May participate as the Regulatory CMC Lead on CMC Teams and represent CMC RA by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations.
- Supporting global regulatory filings for development compounds and marketed products in collaboration with other CMC RA senior personnel.
- Preparing regulatory dossiers for submission to Health Authorities under supervision.
- Coordinating, compiling, and managing CMC country specific documents required as part of the approval process for global submissions.
- Assisting in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
- May participate in selected initiatives within CMC RA / GRA.
- Driving a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.
- Communicates critical issues to Management.
Requirements
- BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 6+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience is required.
- 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.
- Demonstrates model behavior that understands what the priorities are and encourages others to drive for results 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
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