Tasks & Responsibilities
-Secure timely and successful marketing authorizations in alignment with Local/Regional/Corporate strategies and plans.
-Maintain the regulatory status of registered products, including managing variation submissions in accordance with company and regulatory authority requirements.
-Ensures local implementation and compliance with Corporate Policies, Processes, Procedures, and Guidelines relevant to regulatory affairs activities.
-Stay informed about local legislation, regulations, and guidelines related to drug registration and pharmacovigilance. Provide feedback to local management and Regional/Corporate regulatory affairs teams on significant changes and future developments.
-Develop and build knowledge for the effective use and maintenance of BI systems and databases.
-Assist in quality-related activities, including local batch release, product complaint and deviation reporting
Requirements
-Previous experience in regulatory affairs within a multinational pharmaceutical company is advantageous. Fresh graduates with relevant knowledge are also welcomed.
-Bachelor’s degree in life-science related disciplines such as Pharmacy, Biochemistry, Biology, Biopharmaceuticals, Pharmacology or relevant science subjects.
-Knowledge in local health authority regulations, including new drug applications, change of registered particulars, etc.
-Detail-oriented, team player, collaborative, passionate and strong learning agility
Ready to Contact Us?
Please contact our Recruiting Team: HK: [email protected]
Position Area
Regulatory Affairs
Position Location
Hong Kong
Organization
Boehringer Ingelheim (HK) Ltd.
Schedule
Full time
