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Take Reg-CMC role for chemical products under clinical development and marketed in China. Support line manager to coordinate CMC regulatory activities with internal and external stakeholders. inlcuding:
1.Provide CMC expertise and develop CMC strategy through all stages of imported drug product development (CTA, NDA and subsequent renewals/variations);
2.Assess and communicate CMC regulatory requirements with internal partners to ensure all CMC submissions are in compliance with applicable regulations and guidelines;
3.Update the organization on the evolving CMC regulatory requirements to ensure all relevant divisions/functions understand the impact and implications and take appropriate actions;
4.Engage and interact with regulatory agencies to reach aligned pathways/solutions for all CMC and QC related issues;
5.Coordinate and align with global team to ensure adequate global support and input in CMC and QC related issues;
6.Drive decision making through communication and alignment across multiple functions/divisions;
7.Interact with all TAs internally to ensure consistent and aligned approaches in CMC and QC related issues. Coordinate the preparation of CMC responses to regulatory agencies;
Who you are:
5-8 years working experience on Regulatory Affairs in Pharma company.
functional area: Regulatory & Medical Affairs
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com