We are currently recruiting an exciting opportunity for a Director Global Regulatory Affairs Category CMC to join our leadership team. The purpose of the position is to lead, coordinate and prioritise Category RA CMC (Chemistry and Manufacturing Control) regulatory activities in alignment with the category and tech excellence. Coordinate strategy and plan for on-time execution & completion of projects within GRA CMC whilst adhering to defined compliance standards. Monitoring assignment of resources and managing work across GRA CMC to deliver projects according to plan, as well as leading direct report(s) and acting as GRA representative to Tech Excellence/Supply chain for the category.
As an active member of a Regulatory Affairs Category team with dotted line to the Category Regulatory Affairs Lead, the incumbent will be in charge of the development and execution of CMC regulatory strategies for all CMC regulatory activities in an assigned portfolio of products.
The position will oversee internal compliance processes (eg EDGE) and ensure best practices are in place aligned to KPIs.
Key Responsibilities
• Responsible for all CMC regulatory matters and activities relating to registrations and life-cycle maintenance for an assigned category portfolio of projects and products. Establishes and communicates the global CMC regulatory strategies.
• Oversees consistent input to project charters and plans, including the business case for value engineering, approach, milestone plan and risk register.
• Works with category to assure alignment of registration strategy for all new or modified formulations and high quality of developments.. Ensures regulatory priorities of the major countries in project scope are considered in the project plans and considers impact of including non-priority countries. Leverages experience across regions for the allocated projects/products and provides regulatory CMC advices on a global basis.
• Provides CMC regulatory expert advice to the cross-functional teams including project and brand team(s) regarding new opportunity evaluations (including due diligence as required) and CMC requirements for new product development, registration and life-cycle maintenance. Interacts with other functions and GRA colleagues to deliver high quality CMC dossiers, documents and materials in accordance with business priorities (e.g. CMC sections of Briefing Books for HAs meetings, INDs/CTAs, NDAs/MAAs). Effectively communicates requirements and guidelines, ensuring timely and complete CMC submissions. Ensures systems and procedures are in place to maintain proper records and support adequate controls.
• Provides CMC supports to local Regulatory Affairs in interactions with local Regulatory Agencies and experts. May interact directly with local Regulatory Agencies via email, phone, or in-person meetings, depending on project/affiliate needs.
• Act as a contributor to the Global Regulatory Intelligence team handling assigned responsibilities/regions (eg EU for EU based roles), potentially covering medicines, cosmetics, devices and foods, liaising with other GSK partners (eg pharma/vaccines) as required.
• May contribute to special assigned activities and projects within the team or represent GRA CMC in cross-functional assignments, projects and as subject matter expert (SME), including change control committees and manufacturing site liaison. May represent GSK CH or GRA CMC in various internal or industry teams, trade associations or professional organizations.
• Oversee major parts of the overall CMC compliance process (EDGE), leading improvement projects inc ensuring KPIs are in place.
• Manage a team of regulatory affairs associates, depending on the size of the assigned portfolio, responsible for objective setting, performance management, and expertise and career development across regions and product types. Empowers and supports team and develops associates potential.
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