Wanchai, HKG
5 days ago
Regulatory Affairs Executive (1 yr Contractor)
**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: joyce.he@boehringer-ingelheim.com **Position Area** Regulatory Affairs **Position Location** Hong Kong **Organization** Boehringer Ingelheim (HK) Ltd. **Schedule** Full time All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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