Chemistry Manufacturing Lead for Regulatory Affairs
Há 2 dias
Job Overview:
Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for.
We are seeking an experienced Chemistry Manufacturing Lead to join our team in Regulatory Affairs. As a key member of our organization, you will be responsible for leading the preparation and submission of CMC dossiers for assigned projects.
About the Role:
This position requires strong project management capabilities, with a proven track record of demonstrated knowledge of CMC life cycle management and eCTD.
You will be responsible for managing processes and connections between external partners and various stakeholders within CMC.
Your Key Responsibilities:
- Manage the preparation and submission of Global CMC dossiers for assigned projects.
- Oversee the development of regulatory strategies and ensure compliance with relevant regulations.
- Cultivate and foster collaborative relationships with internal and external partners to drive on-time delivery of business commitments.
- Monitor, facilitate, report, and communicate progress against agreed timelines.
- Escalate 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.
- Or an advanced degree (MS, MBA, Ph.D., PharmD) with a minimum of 4 years of relevant experience.
- Strong negotiation, interpersonal, written/oral communication skills, and fluency in English.
- Ability to lead by influence and work effectively in matrix organizational structures.
- Project Management experience.
- Good understanding of change management projects.
About Organon:
As an equal opportunity employer, we welcome applications from candidates with diverse backgrounds.
We are committed to creating an inclusive environment for all our applicants.
Estimated Salary Range:$120,000 - $180,000 per year
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