Sr. Scientist, Regulatory Affairs - Chemistry, Manufacturing & Controls (CMC)The Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned products in accordance with global regulations, guidance's, and defined regulatory strategies. The Senior Scientist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for life-cycle maintenance submissions and post-approval changes. The candidate may also support project team goals and organizational initiatives on an as-needed basis. Primary responsibilities include, but are not limited to:
Responsibilities 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 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.Liaise 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.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 our company's Regulatory CMC management, as needed.Required Education, Experience and Skills Bachelor's degree in a science, engineering, or a related scientific field. Fields of study include Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmacy, Microbiology, Virology, or Molecular Biology with at least four years of overall relevant work experience ORAdvanced degree (MS, MBA, Ph.D., PharmD) in a science, engineering, or related scientific field. Fields of study include Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmacy, Microbiology, Virology, or Molecular Biology with at least two years of overall relevant work experience.Minimum of two (2) years of relevant CMC experience, including biological/pharmaceutical research; manufacturing, testing, or a related field.The candidate must be proficient in English; additional language skills are a plus.Technical Skills 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 guidelines.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.Familiar with regulatory guidelines for product post-approval change management and data requirements.Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).Leadership Skills 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.Managing multiple projects to ensure on-time deliverables and timely submissions to ensure product supply continuity.Preferred Experience and Skills Direct experience in Regulatory CMC and/or authoring of regulatory documentation.Device and/or combination product regulatory experience.Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
#J-18808-Ljbffr