Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing & Controls (CMC)LisboaEUR 60000 - 80000Job DescriptionThe PositionThe Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects. The individual may also support project team goals and organizational initiatives on an as needed basis.This will include oversight and monitoring of assigned CMC project timelines. This position will work alongside CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress in achieving project goals. The position will also be responsible for providing CMC support to the Network Project CMC Lead for project strategy formulation.Additionally, this position will involve working with outsourced support for Network activities in alignment with the OMS CMC outsource strategy. This includes proactive collaboration with external partners to monitor, report, and act on delivery performance and quality of deliverables.The incumbent requires in-depth knowledge and skills in CMC strategy, with strong project management capabilities. A strong track record of demonstrated knowledge of CMC life cycle management and eCTD is essential for the successful candidate.ResponsibilitiesManage processes and connections between the external partners and the various stakeholders within CMC, serving as the CMC Lead for assigned Global Network projects and being accountable for the delivery of all regulatory milestones.Oversee the preparation and submission of Global CMC dossiers for assigned Network projects.Cultivate and foster collaborative relationships with internal and external partners to drive on-time, high-quality delivery of business commitments.Actively monitor, facilitate, report, and communicate progress against agreed timelines, proactively resolving issues to enable delivery of high-quality, on-time submission information.Escalate potential delays or performance issues promptly to impacted, cross-functional stakeholders.Manage communication and change management within the internal organization.Provide CMC support for Legal Entity Change (LEC) projects.Required Education, Experience and SkillsBachelor's degree in a science, engineering, or a related field (Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology) with a minimum of 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field.Or an advanced degree (MS, MBA, Ph.D., PharmD) with a minimum of 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field.Strong negotiation, interpersonal, written/oral communication skills, and fluency in English.Ability to lead by influence and work effectively in matrix organizational structures.Good understanding of change management projects.Preferred Education, Experience and SkillsDegree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline.Direct experience in Regulatory CMC.Demonstrated experience in driving change initiative projects.Who We AreOrganon 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 diverse backgrounds. We are committed to creating an inclusive environment for all our applicants.
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