Senior Regulatory Affairs Associate
Location Hong KongFULL_TIME
Consultant Claire Zhou
Date posted 14 April 2023hong-kong healthcare/healthcare-sales-and-marketing 2023-04-17 2023-06-13 pharmaceuticals Hong Kong HK Robert Walters https://www.robertwalters.com.hk https://www.robertwalters.com.hk/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true
Our client is a U.S listed medical company focusing on woman's health products. Currently looking for a Senior Regulatory Affairs Associate to support their fast-growing team.
- Provide regulatory support on data collection, database maintenance, record tracking and report dissemination
- Support regulatory submission, review and approve required documents, make regulatory filing determinations for product and process changes
- Maintain high standard of regulatory compliance and deliver projects on a timely basis
- Work closely with the team and report to the Senior Manager; Liaise and collaborate with various stakeholders in relation to all regulatory issues
- Maintain current information and awareness of regulatory intelligence, including regulatory agency guidance and procedures, and provides updates to the teams
- May have opportunities to cover Quality Assurance (QA)/ Pharmacovigilance (PV)
- Bachelor’s degree in Medical Science or relevant discipline is preferred
- 3+ years of hands-on work experience in regulatory, preferably in pharmaceutical/ medical device company
- Passion and experience in women health is highly preferred
- Deep understanding and knowledge of HK regulatory affairs principles, practices and systems, especially in the area of pharmaceutical/ medical devices
- History of successful submission of regulatory filings, with acceptance or approval by regulatory agencies
- Ability to read, analyze, and interpret technical dossiers, general business periodicals, professional journals, technical procedures, and governmental regulations
- Excellent communication skills, including writing, verbal, interpersonal skills, and negotiating skills
- Good commands in spoken and written Cantonese and English
Get in touch
+852 2161 9423
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