Regulatory Affairs Specialist

1 month ago

Canada Organon LLC Full time

Regulatory Affairs Specialist

**Job Summary**

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.

**Key Responsibilities**

* Lead the preparation and submission of CMC dossiers for assigned Network Projects
* Collaborate with CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress towards project goals
* Provide CMC support to the Network Project CMC Lead for making strategy for projects
* Work with outsourced support of Network activities in alignment with the OMS CMC outsource strategy
* Proactively collaborate with external partners to monitor, report, and act on delivery performance and quality of deliverables

**Requirements**

* Bachelor's degree in a science, engineering, or a related field
* Minimum 7 years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field
* Strong negotiation, interpersonal, written/oral communication, and fluent in English language
* Project Management
* Good understanding of change management projects
* Direct experience in Regulatory CMC
* Demonstrated experience driving change initiative projects

**About Organon LLC**

Organon LLC is a 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.

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