Russell Oakley at CK Group is currently sourcing for a CMC Regulatory Professional for a 12 month contract working for a multinational Pharmaceutical company based in Slough.
This role has been deemed Inside IR35 wo you will need to work through CK Group payroll or via an Umbrella Co.
The Biologics Development Products Centre of Expertise is responsible for regulatory CMC for all NBE products in development.
Provide support, or lead as assigned, regulatory CMC submissions for all products within the scope.
- Support for developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
- Identifies supporting documents required for regional submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Responsible for writing regional and global CMC documentation for submissions as agreed with the Global Regulatory CMC Lead or (Global) Regulatory CMC Scientist if applicable, in line with agreed global regulatory strategy, and within agreed timelines.
- Highlights anticipated and ongoing critical issues arising through the product life-cycle in a timely manner to enable communication to key stakeholders (including TSO Practice Teams, GRA Practice Teams, PVU through the PVU GRL and the appropriate management level in the TSO Practice) as appropriate.
- Contribute to the preparation of the CMC SWOT analysis (or regulatory Risk Capture Document) and supports associated RA CMC challenge sessions.
- Leads or provides support to all CMC related interactions to facilitate and ensure satisfactory resolution of CMC issues and negotiates CMC approvals with HAs in regions assigned, as delegated by the Global Regulatory CMC Lead (or Global Regulatory CMC Scientist if applicable) for assigned projects/products.
- Leads or provides support to cross-functional teams responsible for the preparation of responses to HA CMC questions raised in regions assigned as delegated by the Global Regulatory CMC Lead (or Global Regulatory CMC Scientist, if applicable) for assigned projects/products.
- Monitors and reacts as appropriate to changes in the CMC regulatory environment in regions assigned for assigned projects/products to support and advice TSO Practice Teams and PVU.
- Establishes and maintains modes for effective communication and collaboration with the Global Regulatory CMC Lead (or Global Regulatory CMC Scientist if applicable), PVU GRL and GRA functions for assigned projects/products.
- Provides regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Trackwise, UPILOT etc.) for assigned regions within defined timelines, as agreed with Global Regulatory CMC Lead (or Global Regulatory CMC Scientist if applicable).
- Provides regulatory affairs CMC input in TO Practice Teams as delegated by Global regulatory lead or scientist.
- Leads or provides input to internal regulatory business initiatives and cross functional work streams as assigned.
- At least 5-8 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity, with at least 5 years of experience in Regulatory Affairs CMC and preferably 3 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical 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
- Experience of direct communication and negotiation with regulatory agencies on CMC matters
- Experience of participating in regulatory agency meetings on CMC matters
- 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
To apply please call Russell Oakley on 01246 457709 to discuss further, quoting reference number 49523
It is essential that applicants hold entitlement to work in the UK
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Russell Oakley
- Phone: 01246 457733
- Reference: 49523
Website: CK Group
- Posted: 24th December 2020
- Expires: 21st January 2021