Regulatory Affairs Chemistry Manufacturing Expert

Há 6 dias


Lisboa, Lisboa, Portugal Organón Tempo inteiro

Organon is seeking an experienced Associate Principal Scientist to join our team in Regulatory Affairs Chemistry Manufacturing. This role will provide critical support for Organon's Network Projects, ensuring timely and high-quality submission of CMC dossiers. The ideal candidate will have a strong background in CMC strategy, project management, and regulatory affairs.

About the Position

This position will oversee the preparation and submission of Global CMC dossiers for assigned Network projects. The successful candidate will be responsible for managing processes and connections between external partners and stakeholders within CMC. A collaborative approach is essential to drive on-time, high-quality delivery of business commitments.

The incumbent will require in-depth knowledge and skills in CMC strategy, with strong project management capabilities. A proven track record of demonstrated knowledge of CMC life cycle management and eCTD is crucial for success. Additionally, fluency in English and strong negotiation, interpersonal, written/oral communication skills are necessary.

Key Responsibilities
  • Manage processes and connections between external partners and stakeholders within CMC.
  • Oversight of preparation and submission of Global CMC dossiers for assigned Network projects.
  • Cultivate and foster collaborative relationships with internal and external partners.
  • Active monitoring, facilitation, reporting, and communication of progress against agreed timelines.
  • Escalation of 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 a minimum of 7 years of relevant experience. Alternatively, an advanced degree (MS, MBA, Ph.D., PharmD) with a minimum of 4 years of relevant experience.



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