Regulatory Affairs Executive (3 yr Contractor)
Regulatory Affairs Executive (3 yr Contractor)
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Job Description
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 signicant 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.
-Bachelors 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:
Position Area
Regulatory Affairs
Position Location
Hong Kong
Organization
Boehringer Ingelheim (HK) Ltd.
Schedule
Full time
Required Experience:
Contract
Employment Type
Full-Time
