Sr Manager, RegCMC Clinical Lead

This role is responsible for regulatory CMC expertise into the development and implementation of the regulatory strategies, operations and planning for the CMC aspects of assigned programs.This role is responsible for regulatory CMC expertise into the development and implementation of the regulatory strategies, operations and planning for the CMC aspects of assigned programs. Responsibilities include preparation and compilation of submission/documentation for specific small molecule, oligonucleotide, biologics, gene therapy projects and/or devices, working as or working with the CMC Global Regulatory Lead and key stakeholders, primary contact for affiliates on regulatory CMC activities in the assigned regions and managing of routine and non-routine regional Health Authority interactions as delegated by the CMC Global Regulatory Lead. Depending on the stage of development and complexity of the program, this role can have responsibilities for CMC Global Regulatory Lead for early stage development programs or working with the CMC Global Regulatory Lead for late stage development programs. For early stage programs, the Regulatory CMC Clinical lead may be the primary global contact for regulatory CMC activities associated with the program. For late stage development programs the Regulatory CMC Clinical lead is the primary contact in the assigned regions (US, Canada, Latin America where located in the USA and EU, MENA, APAC where located in the Europe). This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, regulatory CMC knowledge and interpersonal skills are required. Duties and Responsibilities: Providing regional and global strategic and operational regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives. Preparation and delivery of CMC regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (IND/IMPD/CTAs) Responsible for regional submission from defining and agreeing content with CMC global regulatory lead to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities in assigned regions. Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions Managing CMC aspects of routine and non-routine regional Health Authority interactions including issue resolution and negotiation of approvals, as delegated. Monitoring changes in the regulatory CMC environment in assigned regions to support and advise CMC global lead and teams. Providing input into regulatory CMC risks assessment and mitigation plans from a regional perspective for assigned regions and ensuring that it remains in line with the overall global regulatory CMC strategy. Coordinating and completing regulatory assessments of CMC changes in the designated systems Responsible for assuming responsibilities from the global regulatory lead, as agreed and delegated and maintaining open lines of communication with the lead on assigned projects/products to ensure awareness on status and issues relating to regional submissions. Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of RegCMC on cross functional work streams Responsible for leading or assisting in delivery of RegCMC initiatives and the development of RegCMC standards and SOPs, as assigned. Ensure that appropriate records are maintained in the designated system for submission in assigned regions Key Contacts and Interactions: Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels. Customer focused: Interacts with a functional area key stakeholder both internally and externally, including subject matter experts, partners and regulatory agency personnel. #LI-SK2Regulatory Skills At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field. Successful authoring and contribution to delivering CMC submission documents of development and marketed products (biological, oligonucleotide, 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 Knowledge of GMP requirements and standard systems (e.g. change management systems) Demonstrate