Senior Regulatory Affairs Compliance Associate - URGENT!!
A. Menarini (Thailand) Ltd.
jobsDB ref: JTH300003001256463
Employer Ref. Free
- Reviewing, preparing and submitting documents and follow up until obtaining approval for product registration.
- Preparing reviewing, and submitting required documents to the FDA.
- Reviewing, preparing and submitting documents for amendment of approved licenses.
- Providing information to principals as requested.
- Reviewing the registration documents, approved licenses and related documents such as certificates of analysis and etc.
- Submitting and follow up until obtaining approval for simple promotional materials.
- Preparing reviewing, and submitting monthly, quarterly, half-year and annual importation and sales reports to FDA.
- Preparing reviewing, and submitting restricted product reports (narcotic/ psychotropic/ new drugs) to the FDA.
- Preparing registration status reports for principals monthly.
- Providing additional documents for products clearance, if required.
- Providing additional documents for hospital biding/ tender, if required
Qualifications and Experience
- Bachelor degree in Pharmacy.
- Minimum 5 years in product registration compliance and related filed.
- Proficient in oral and written English.
- Computer literacy (Word, Excel, PowerPoint).
- Proven inter-personal skills.
jobsDB will send your application for review directly to A. Menarini (Thailand) Ltd.
About A. Menarini (Thailand) Ltd.
Menarini Asia-Pacific (Formerly Invida Group) Menarini Asia-Pacific, a fully owned member of the Menarini Group, improves the lives of patients in Asia-Pacific by commercializing differentiated pharmaceutical and OTC brands. This is done through proven brand marketing and sales know-how, strong expertise across a number of key therapeutic categories and deep experience in all major Asia-Pacific markets. Comprehensive functional capabilities provide rapid market access delivered by a passionate team of sales and marketing professionals. With over 3,300 employees in 13 key markets in Asia-Pacific, Menarini Asia-Pacific operates across the commercial value chain from regulatory approval and product launch to lifecycle management. Partnering is an integral component of Menarini Asia-Pacific‟s business model. We collaborate closely through long-term relationships with selected partners in developing effective strategies and putting our extensive experience behind maximizing the potential of the assets entrusted to us. For further information please visit: www.menariniapac.com