Senior Regulatory Affairs Chemist

Há 1 mês


Lisboa, Lisboa, Portugal Organón Tempo inteiro
About the Role

The Associate Director Chemistry Manufacturing Controls Regulatory Affairs will provide regulatory support for Organon Network Projects.

Key Responsibilities
  1. Lead CMC project timelines and oversee preparation and submission of CMC dossiers.
  2. Work alongside CMC Product Leaders and Network Teams to ensure progress towards project goals.
  3. Collaborate with external partners to monitor, report, and act on delivery performance and quality of deliverables.

The successful candidate requires in-depth knowledge and skills in CMC strategy, project management, and eCTD. A strong track record of demonstrated knowledge of CMC life cycle management is necessary.

Requirements
  • Bachelor's degree in a science, engineering, or related field.
  • Minimum of 7 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing, or a related field.
  • Strong negotiation, interpersonal, written/oral communication, and fluency in English language.

Project Management skills and ability to lead by influence are also required. The candidate should be able to work effectively in matrix organizational structures and manage communication and change within the internal organization.

Additional responsibilities will include providing CMC support for Legal Entity Change (LEC) project and working with outsourced support of Network activities in alignment with the OMS CMC outsource strategy.



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