Sr Scientist Product Lead CMC RA

Job Function:

Discovery & Pre-Clinical/Clinical Development

Regulatory Science

Scientific/Technology

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities to be in our East Coast USA locations, Beerse (Belgium) or Warsaw (Poland)

• Contributes 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.
• Supports global regulatory filings for mainly development compounds, and potentially also marketed products, in collaboration with other CMC RA senior personnel.
• Prepares regulatory dossiers for submission to Health Authorities under supervision.
• Coordinates, compiles, and manages CMC country specific documents required as part of the approval process for global submissions.
• Assists in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
• May participate in selected initiatives within CMC RA / GRA.
• Drives a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.

• May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds (and marketed products).
• Ensures the CMC regulatory strategy is in alignment with the strategies of global regulatory affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP).
• Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader) or other senior level CMC RA personnel.
• Provides input to and assists in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations).
• Assists in providing accurate regulatory assessments of CMC changes to teams for execution of regulatory planning and implementation.
• Escalates issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product.
• Assists in execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Provides CMC Regulatory support to health authority inspections.

• 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 or equivalent. An MS, Ph.D., or Pharm.
  
  D. degree preferred.
• Demonstrated ability to communicate regulatory requirements.
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
• Prior drug development, analytical development, or manufacturing experience.
• Strong attention to detail with high-level verbal and written communication skills.
• Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.
• Experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff.
• Working knowledge of global HA laws, regulations and guidances.

• BS in biological, pharmaceutical, chemical or engineering…