Regulatory Affairs Specialist
Company is a research-driven pharmaceutical company and one of the top 20 pharmaceutical firms worldwide. Headquartered in Ingelheim, Germany, Company operates globally in over 100 countries and has more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2014, Company achieved net sales of about 13.3 billion euros. R&D expenditure cor
Ha Noi
Description:
- To achieve timely & successful product registrations in accordance with corporate & local strategies and to protect and improve the regulatory position of marketed products.
- To update the Company on new Regulations and Guidelines, and to ensure the Company complies with the local legislations & industry codes governing the import and control of AH' products
- To ensure compliance with Company regulatory policies, principles & procedures.
- To make contribution on successful business cases through efficient alignment with and strong support for internal Dept's.
Duties & Responsibilities:
Product Registration & Registration Maintenance (AH)
- Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operation licenses on behalf of BI as required by local regulations.
- Develop & implement local registration plans and strategies.
- Compile registration applications for new products and variations to marketed products.
- Monitor progress of submissions & coordinate timely responses to all questions from the Regulatory
Authorities.
- Compliance with Corporate policies, principles & procedures, in particular implementation of current ELAN,CPD3 and local change control procedures.
- update and train PV for BIAH employees timely.
- lead quality testing project for each shipment before it release to the market.
Duty 1
Requirements:
- Veterinary degree holder
- More than 3 years proven track record working for RA in AH industry
- Solid understanding of animal health development
- Has ability and confidence to communicate professionally with Regulatory Authorities and other external and internal people
- Good knowledge of animal health regulation and Procedures.
- Excellent command of English language.
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Industry:
Pharmaceutical
Job Category:
Pharmaceuticals
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Location:
Ha Noi
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