A global biotechnology company is looking for a brand new Regulatory Affairs Manager to be based in Shanghai, China. Focusing on oncology therapy, you will be playing a pivotal role in developing and implementing regulatory affairs strategies and liaising closely with the Chinese Health Authorities.
Main responsibilities include:
- Keep abreast on regulations and quality standards updates in the industry. Provide advice to management team should any updates/changes impact products in the region and ensure implementation of resulting actions so as to comply to NMPA
- Review product registration strategies and action plans. Make recommendations to adjust the strategies to business management team whenever necessary.
- Assumes the role as an internal examiner and provide regulatory advice to team members in preparation of technical dossiers for submission. Ensures timely registration approvals and permits being obtained.
- Interact with and build rapport with regulatory agencies and notified bodies as required to perform effective and fast track approval of product registrations.
- A degree in scientific discipline or equivalent
- Minimum 8 years in the field of regulatory affairs management within the healthcare industry (preferably cell therapy related) with strong relationships established with Health Authorities
- Good English communication skills are preferred to communicate with global offices
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).