.PositionThe Associate Principal Scientist is responsible for facilitating and implementing Regulatory CMC strategies for assigned small molecule products supporting Site of Source Changes in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist is responsible for the preparation and review of regulatory CMC dossiers for MSA network changes with health authorities.The incumbent will work with CMC Product Lead and may manage outsourcing partners in support of project execution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as-needed basis.ResponsibilitiesWork with the CMC Product Lead for assigned project and be accountable for the delivery of all regulatory milestones for assigned projects.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.Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes, identification of global regulatory requirements, and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.Execute regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support post-approval supplements and responses to health authority questions per established business processes and systems.Collaborate with our 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.Manage execution of CMC documentation including post-approval supplements 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.Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.Assess and communicate potential regulatory risks and propose mitigation strategies.Deliver all regulatory milestones for assigned projects.Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as needed.Required Education, Experience and SkillsBachelor's degree in a science, engineering, or a related field - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology or Biochemistry with at least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D