Regulatory Chemistry Manufacturing and Controls Associate Director

2 semanas atrás

Lisboa, Lisboa, Portugal Organon Tempo inteiro
Job Description

The Associate Director, Regulatory Chemistry Manufacturing and Controls, will provide regulatory CMC support for Organon Network projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects. The individual will also support project team goals and organizational initiatives as needed. This will include oversight and monitoring of assigned CMC project timelines. The position will work alongside CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress towards project goals. The position will also be responsible for providing CMC support to the Network Project CMC Lead for making strategy for projects. This position will also be responsible for working with outsourced support of Network activities in alignment with the OMS CMC outsource strategy. This includes proactive collaboration with external partners to monitor, report, and act on delivery performance and quality of deliverables.

Responsibilities
  • Manage processes and connections between external partners and various stakeholders within CMC.
  • Serve as the CMC Lead for assigned Global Network projects and be accountable for the delivery of all regulatory milestones.
  • Oversee the preparation and submission of Global CMC dossiers for assigned Network projects.
  • Cultivate and foster 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 and proactively resolve issues to enable delivery of high-quality, on-time submission information.
  • Escalate potential delays or performance issues in a timely manner to impacted, cross-functional stakeholders.
  • Manage communication and change management within the internal organization.
  • Provide CMC support for Legal Entity Change (LEC) project.
Requirements
  • Bachelor's degree in a science, engineering, or a related field (Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry).
  • Minimum seven years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field.
  • Or advanced degree (MS, MBA, Ph.D., PharmD) - minimum four 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.
  • Ability to lead by influence and work effectively in matrix organizational structures.
  • Project Management.
  • Good understanding of change management projects.

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