Principal Scientist, Global Regulatory Affairs, CMC

• Participate as the Regulatory CMC Lead on CMC/Value Chain Teams and represent CMC Regulatory Affairs
• Provide regulatory expertise and input to team recommendations for global product development
• Participate on Global Regulatory Teams and develop global submission plans
• Develop and execute global CMC regulatory strategies for large-molecule, vaccine, cell and gene therapy, and delivery-device products
• Lead preparation of regulatory dossiers for Health Authority submissions
• Develop regulatory CMC strategies for Health Authority responses and interactions
• Participate in CMC RA / Global Regulatory Affairs initiatives
• Drive continuous improvement and compliance with company standards and regulatory requirements
• Communicate critical issues to management and represent CMC RA on cross-functional teams
• Serve as a SPOC/SME on internal and external teams
• Ensure product regulatory strategies meet global requirements throughout the product lifecycle
• Maintain connectivity with the overall global regulatory strategy through partnership with Therapeutic Area Regulatory Affairs
• Escalate registration, compliance, and lifecycle-management issues and develop contingency plans
• Communicate with health authorities and maintain positive professional relationships
• Review CMC regulatory dossiers throughout the product lifecycle
• Assess CMC changes and execute regulatory planning and implementation

• BS/BA in biological, pharmaceutical, chemical, or engineering sciences required, with 8+ years of experience inclusive of postgraduate education and/or pharmaceutical or healthcare industry experience or equivalent
• Solid understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry
• Experience in biologics and product development/lifecycle management of large molecules
• Experience developing regulatory strategies and understanding product development preferred
• Knowledge of EU and FDA regulations preferred
• High-level verbal and written communication skills
• Strong attention to detail
• Ability to potentially travel up to 10% domestically and/or internationally
• MS, Ph.D., or Pharm.
  
  D. preferred

Demonstrates expertise in developing and executing global CMC regulatory strategies for large-molecule, vaccine, cell and gene therapy products, ensuring compliance with EU and FDA regulations. Strong communication skills facilitate effective collaboration with health authorities and cross-functional teams throughout the product lifecycle.

• Regulatory CMC Strategy Development
• Health Authority Submission Preparation
• Biologics Product Development
• EU and FDA Regulatory Knowledge
• Lifecycle Management

• Regulatory Dossier Preparation
• CMC Regulatory Strategy
• Biologics Experience
• Product Development
• Regulatory Planning
• Compliance Management
• Pharmaceutical Industry Knowledge
• Attention to Detail
• Global Submission Planning
• Health Authority Interaction

• High-Level Communication Skills
• Cross-Functional Team Collaboration

• BS/BA in Biological Sciences
• MS, Ph.D., or Pharm.
  
  D. Preferred

• Pharmaceutical Industry
• Regulatory Affairs
• Large Molecules
• Vaccine Development
• Cell and Gene Therapy
• Delivery-Device Products
• Continuous Improvement
• Global Regulatory Teams
• Therapeutic Area Regulatory Affairs
• Lifecycle Management Issues