Senior Regulatory Affairs Lead for Chemistry and Manufacturing

1 semana atrás


Lisboa, Lisboa, Portugal Organón Tempo inteiro

At Organon, we're committed to delivering ingenious health solutions that empower people to live their best lives. Our team is seeking a skilled Senior Regulatory Affairs Lead to oversee Chemistry and Manufacturing strategies across our Network Projects. This critical role will lead the preparation and submission of CMC dossiers, collaborating with cross-functional stakeholders to ensure timely and high-quality deliverables.

About the Role

This Senior Regulatory Affairs Lead position requires strong project management capabilities, in-depth knowledge of CMC strategy, and excellent communication skills. The ideal candidate will have a proven track record of driving change initiatives and fostering collaborative relationships with internal and external partners.

Key Responsibilities:
  • Manage processes and connections between external partners and various 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 to drive on-time, high-quality delivery of business commitments.
  • Active monitoring, facilitation, reporting, and communication of progress against agreed timelines, resolving issues promptly to enable delivery of high-quality, on-time submission information.
Requirements:

To succeed in this role, you'll need:

  • 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.
  • Able to lead by influence and work effectively in matrix organizational structures.
  • Project Management experience.
What We Offer:

We provide a competitive annualized salary range of $140,000 - $160,000, depending on location, as well as opportunities for growth and development within our organization.

Please note that relocation assistance is not available for this position, but visa sponsorship is offered for eligible candidates. Travel requirements are moderate, approximately 10% of the time. A valid driving license is necessary, and hazardous material handling training may be required.



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