Senior Regulatory Affairs Specialist, CMC Strategy Expert
1 semana atrás
Job Overview
The position of Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing at Organon is responsible for providing regulatory support for Organon Network Projects. This includes leading the preparation and submission of Chemistry, Manufacturing & Controls (CMC) dossiers for assigned projects.
Main Responsibilities
- Manage processes and connections between external partners and various stakeholders within CMC.
- Oversee the preparation and submission of Global CMC dossiers for assigned Network projects.
- Cultivate 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.
- Escalate potential delays or performance issues promptly to impacted stakeholders.
Requirements
- Bachelor's degree in a science, engineering, or related field (Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology) with 7+ years of relevant experience.
- Or an advanced degree (MS, MBA, Ph.D., PharmD) with 4+ years of relevant experience.
- Strong negotiation, interpersonal, written/oral communication skills, and fluency in English.
- Ability to lead by influence and work effectively in matrix organizational structures.
Estimated salary range: $120,000 - $180,000 per year.
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