Regulatory Affairs Specialist

2 months ago


Canada Organon LLC Full time

Organon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Chemistry, Manufacturing & Controls (CMC) department, you will be responsible for providing regulatory CMC support for our Network Projects. Your expertise will be crucial in leading the preparation and submission of CMC dossiers for assigned Network Projects. You will work closely with our CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress towards project goals. Your responsibilities will include oversight and monitoring of assigned CMC project timelines, as well as providing CMC support to the Network Project CMC Lead for making strategic decisions. You will also be responsible for working with outsourced support of Network activities in alignment with our OMS CMC outsource strategy. This includes proactive collaboration with external partners to monitor, report, and act on delivery performance and quality of deliverables. You will require in-depth knowledge and skills in CMC strategy, with strong capability in project management. You will serve as the CMC Lead for assigned Global Network projects and be accountable for the delivery of all regulatory milestones. Your qualifications include a Bachelor's degree in a science, engineering, or a related field, or an advanced degree (MS, MBA, Ph.D.) with a minimum of 4 years of relevant experience. You must have strong negotiation, interpersonal, written/oral communication, and fluency in English. Project Management and good understanding of change management projects are also essential. Direct experience in Regulatory CMC and demonstrated experience driving change initiative projects are highly desirable. If you are a motivated and experienced professional looking for a challenging role, we encourage you to apply.



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