Job Information
Organon Senior Scientist, Regulatory CMC in Jersey City, New Jersey
Implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for small molecule or biological products in accordance with global regulations, guidances and defined regulatory strategies. Prepare and review information required for development of regulatory CMC dossiers for commercial products. 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 regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Liaise with Organon 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 Organon Regulatory CMC management, as needed. Must have a Master's degree in Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry or Regulatory Affairs and at least two (2) years of relevant experience that includes experience in biological/pharmaceutical research, manufacturing and testing or a Bachelor's degree in Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry or Regulatory Affairs and at least four (4) years of relevant experience that includes experience in biological/pharmaceutical research, manufacturing and testing. Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data also required. Must also possess demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner; strong listening skills; and demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance). Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders; demonstrated flexibility in responding to changing priorities or dealing with unexpected events; capability to handle multiple priorities and balance work to achieve business goals; and demonstrated effective leadership, communication, and interpersonal skills, also required. 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#: R526688