The purpose of this role is to be responsible for the regulatory CMC activities for new registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products within the category and in particular the regulatory CMC strategy of new product developments and major CMC changes. Incumbent may oversee specific elements of internal compliance processes and ensure best practices are in place aligned to KPIs. The CMC Senior Manager may mentor a team of manager(s) and/or associate(s); in that case, he/she would have the overall accountability of the portfolio supported by the team. The CMC Senior Manager may be a Subject Matter Expert, bringing in the role and/or developing particular expertise in the regulations of a (set of) country/ies or on a specific field in CMC. In that role the CMC Senior Manager would be expected to provide guidance across the wider CMC team and to other functions in his/her field of expertise. Key Responsibilities Responsible for CMC regulatory matters and activities relating to new registrations and life-cycle maintenance for an assigned category portfolio of projects and products. Establishes and communicates global CMC regulatory strategy. Provide oversight/ mentorship for a portfolio and/or technical leadership on specific CMC topics Provides consistent input to project charters and plans, including Regulatory/CMC inputs into the business case for value engineering, approach, milestone plan and risk register for assigned products/projects. Works with Regulatory Category, Regional & PLM, product development, supply chain and tech excellence to assure alignment of registration strategy for all new or modified formulations and high quality of submission packages. Ensures regulatory requirements 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 advice 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 Regulatory Category, Regional & PLM 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). 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. Supports registrations, variations and renewals including responses to Regulatory Agency CMC questions. Participates on the Regulatory Expert Teams of Global and local Regulatory Affairs colleagues to develop and implement regulatory strategies (when required) for all countries in product scope. Ensures regulatory priorities of all major countries in project scope are considered in the project plans and considers impact of including non-priority countries. Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of internal process records. Effectively communicates (technical) regulatory requirements and guidelines, ensuring timely and complete submissions. May act as a contributor to the Global Regulatory Intelligence team handling assigned responsibilities/regions (e.g. EU for EU based roles), potentially covering medicines, cosmetics, devices and foods. May oversee parts of the overall CMC compliance process, leading improvement projects ensuring KPIs are in place. May be involved in site or Notified Body audits when required. May contribute to special assigned activities and projects within the team or represent GRA in cross-functional assignments, projects and as subject matter expert (SME). Qualifications BA or BSc- Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering), RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP Position requires practically applied demonstration of intellect and an ability to interface effectively with R&D, supply chain and commercial counterparts with credibility 8 plus years experience in Regulatory Affairs, Quality & Manufacturing Product lifecycle support ensures compliance and requires regulatory strategy and filing of submissions at a global level. Oversight of the defined products requires a strong background in medicines, devices, cosmetics or dietary supplements. List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. .
