Global Regulatory CMC Scientist

Proclinical has partnered with a multinational pharmaceutical company in search for a Global Regulatory CMC Scientist to join the office in Slough. In this role you will be 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.

Job Responsibilities

• 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 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.

Skills and Requirements

• 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

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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