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.

Regulatory CMC Scientist - Biologics