Senior Manager/Associate Director RA CMC - Biologics
BioTalent are delighted to be supporting our Biotechnology client on an exclusive basis for the hiring of two new exciting roles. One role is to support early phase and development CMC, the other to support marketing authorisations and post-approval CMC objectives. Overview:
- Define the strategy, planning and preparation of CMC documentation and sections for regulatory submissions from a global perspective to achieve timely approvals to meet business needs.
- Lead and ensure adequate provision of regulatory CMC input to all Health Authority interactions on CMC matters in all regions, as agreed with Leadership Teams.
- Lead or provide input to internal regulatory business initiatives and cross functional work streams as assigned.
- Coach and mentor the staff members and provide input to internal CMC initiatives and/or cross functional work streams as assigned by the Leadership Team.
- Responsible for strategy, planning, definition of content, preparation, review and approval of global CMC submissions for assigned projects/products to achieve timely approvals to meet business needs.
- Ensures that the global CMC regulatory strategy for assigned projects/products is consistent with the goals and objectives of Leadership Teams.
- Identifies supporting CMC documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Accountable for writing and approval of CMC sections for submissions (i.e. for briefing documents, clinical trial applications, MAA/BLA/NDA registrations, post-approval submissions, PIPs) and responses to health authority questions in line with agreed global regulatory strategy, and within agreed timelines.
- Highlights and proactively communicates anticipated and ongoing critical issues throughout the product life-cycle in a timely manner to key stakeholders, as appropriate.
- Leads the preparation of the CMC regulatory risk assessment or regulatory risk capture document (i.e. global dossier risk analysis and mitigation/resolution strategies) and coordinates the associated RA CMC challenge session.
- Facilitates capture and communication of CMC lessons learned from major submissions for assigned projects/products.
- Responsible for all CMC related HA interactions, including negotiation and satisfactory resolution of CMC issues to facilitate CMC approvals in all regions.
- Leads cross-functional teams responsible for the preparation of responses to HA CMC questions for assigned projects/products.
- Accountable for the coordination and overall approval of regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Track wise, UPILOT, etc.) within defined timelines.
- Around 10 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity.
- Regulatory experience with Gene Therapy products is a plus
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological entities
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
- Extensive experience of participating in regulatory agency meetings on CMC matters