Regulatory Affairs Chemistry Manufacturing Associate Director

2 semanas atrás

Lisboa, Lisboa, Portugal Organón Tempo inteiro
Job Title: Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing

Job Summary:

The Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing 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 may also support project team goals and organizational initiatives on an as-needed basis.

Key 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 such as Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, or Molecular Biology.
  • Or advanced degree (MS, MBA, Ph.D., PharmD) with a minimum of 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field.
  • Minimum of 7 years of relevant experience if holding a bachelor's degree.
  • 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 skills.
  • Good understanding of change management projects.

Preferred Requirements:

  • Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline.
  • Direct experience in Regulatory CMC.
  • Demonstrated experience driving change initiative projects.

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