Implement regulatory Chemistry, Manufacturing, & Controls (CMC) strategies for assigned products in accordance with global regulations, guidance, and defined regulatory strategies. Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, original registrations, life-cycle maintenance submissions, and post-approval changes. Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks. Execute global regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support global development (IND, IMPD), new registrations (NDA, MAA), post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Ensure product compliance through timely and accurate maintenance of CMC submissions in the systems. Liaise with company's Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to company's Regulatory CMC management, as needed. Must have a Master’s degree in Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmaceutical Sciences, Microbiology, Virology, or Molecular Biology and at least 3 years overall relevant work experience including 3 years direct experience in formulation, analytical or chemistry process development or a Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmaceutical Sciences, Microbiology, Virology, or Molecular Biology and at least 4 years overall relevant work experience including 3 years direct experience in formulation, analytical or chemistry process development. Additionally possess experience in authoring and reviewing of Regulatory CMC related documentation, evaluation of Subject Matter Expert (SME) technical documentation for completeness and sufficient details in order to make accurate regulatory assessments through utilization of current global regulatory guidance, and reviewing of scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. Must possess familiarity with regulatory guidelines for product development, new registrations, post-approval change management and data requirement. Must have demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner; strong listening skills; understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance); understanding of manufacturing, specification setting and stability protocols related to the pharmaceutical business and understanding of the principles of cGMP. Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; demonstrated flexibility in responding to changing priorities or dealing with unexpected events; demonstrated effective leadership, communication, interpersonal, and negotiating skills; and ability to manage multiple projects to ensure on-time deliverables and timely submissions to ensure product supply continuity also required. 40 hours per week. Telecommuting permitted. Must have proof of legal authority to work in the United States. To apply, visit Organon LLC’s career site at https://jobs.organon.com to create a profile and submit your CV for Job Req#: R532539