Job DescriptionAlthough one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants.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, 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., PharmD) with at least 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.Preferred - degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline.Strong negotiation, interpersonal, written/oral communication and fluent in English language.Ability to lead by influence and work effectively in matrix organizational structures.Project Management.Good understanding of change management projects.Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem-solving.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.Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.Preferred Experience and SkillsA candidate with experience in Regulatory CMC post-approval lifecycle management is preferred.Direct experience in Regulatory CMC is preferred.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.Search Firm Representatives Please Read CarefullyOrganon LLC does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Annualized Salary RangeEmployee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites 10%Flexible Work Arrangements: Flex TimeShift:Valid Driving License:Hazardous Material(s):Number of Openings: 1Requisition ID: R530692
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