RA Manager

职位描述

Top MNC Pharmaceutical Company, global role

The main responsibilities are:
•Provide expertise in Chinese regulatory affairs leading to the accurate and timely preparation and submission of regulatory dossiers.
•Represent in the relevant regulatory bodies and associations.
•Evaluate changes in the regulatory and pharmacopoeial standards.
•Conduct impact assessments and implementation plans to ensure compliance to latest requirements.
•Answer RA related questions of internal and external stakeholders.
•Communicate to global team on regular basis any updates in:
Chinese Drug Master Files
Chinese regulations on excipients, used for pharmaceutical and nutraceutical applications, in China.
Chinese pharmacopoeia requirements
IPEC China activities
•Train relevant staff on regulatory issues, and provide regulatory seminars in the market.

Job Requirements

Required qualifications:
•A Bachelor’s degree (as a minimum) in Pharmacy, (Bio) Chemistry, Food Technology or equivalent
•At least 10 years working experience in regulatory affairs in the Pharmaceutical industry in China
•Hands on experience with filing Chinese Drug Master Files
•Extensive knowledge of pharmaceutical regulations
•Knowledge of dairy and/or food legislation would be of advantage
•Able to influence stakeholders on regulatory topics
•Proactive & solution-oriented mindset.
•Capability to work in multidisciplinary team
•Outstanding verbal and written communication in English
•Excellent oral and written communication skills