Regulatory Affairs Chemistry Manufacturing Senior Specialist
4 semanas atrás
Job Description
The Position
Biom?Rieux Bv is seeking a skilled Regulatory Affairs Chemistry Manufacturing Senior Specialist to provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects, while working alongside CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress to achieve project goals.
Responsibilities
1. Serve as the CMC Lead for assigned Global Network projects, being accountable for the delivery of all regulatory milestones.
2. Oversee preparation and submission of Global CMC dossiers for assigned Network projects.
3. Cultivate and foster collaborative relationships with internal and external partners to drive on-time, high-quality delivery of business commitments.
4. Actively monitor, facilitate, report, and communicate progress against agreed timelines and proactively resolve issues to enable delivery of high-quality, on-time submission information.
Requirements
Bachelor's degree in a science, engineering, or a related field, or advanced degree, with a minimum of 4 years of relevant experience in 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. Project Management skills.
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