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Regulatory CMC Scientist - Biologics

Job description

RA CMC Manager/Senior Manager

Responsibilities:
 
  • Define the strategy, planning and preparation, writing and review of CMC submission documentation for regulatory submissions from a global and regional perspective to achieve timely approvals to meet business needs.
  • Provide regulatory CMC leadership on the cross functional sub teams and advise on best practices and/or supports Commercial Teams, as assigned by the Leadership Team.
  • Contribute and ensure adequate provision of regulatory CMC input to all Health Authority  interactions on CMC matters in all regions
  • Ensures effective communication of CMC regulatory strategy, risks, and overall plan to Global RA Teams, Development and Commercial Teams
  • Highlights anticipated and ongoing critical issues arising through the product life cycle in a timely manner to Global RA to enable communication to key stakeholders.
  • Lead or provide input to internal regulatory business initiatives and/or cross functional work streams as assigned by the Global RA Leadership Team
 
Experience:
 
  • Bachelor’s degree, Master’s preferred in a relevant life science or business-related discipline
  • Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC and/or in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field, or a regulatory authority in a CMC review capacity
  • Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
  • Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
  • Demonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structure
  • Effective interpersonal, presentation and communication skills with established internal and external stakeholders
  • Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills.