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Mô Tả Công Việc
- Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical medical products and ensure products, which are developed, manufactured or distributed by company, meet the required legislation.
* Job description:
– Responsible for all activities pertaining to product registration, regulatory submissions and national programs which Pfizer initiates including registration amendments, drug reports, promotion activities, company registration/ renewals.
– Developing packaging artworks of registered products, ensuring compliance to the company SOP and ensuring that the company’s legal compliance is in line with relevant regulations.
– Providing regulatory advice to Company colleagues.Primary Responsibilities:
1. Regulatory Submission & Approval (renewal registration, variation registration, new registration as assigned by RAL):
– Prepares, submits, coordinates and follows up on product registration as assigned.
– Variation registration: CMC, labeling update, artwork change…
– Ensure timely approval according to product registration plan.
– Keep contact with concerned parties abroad or in local.
– Supply the required information/documents for requirements of external or internal colleagues including Health Authorities (Ministry of Health) to conform to Company’s regulations and law.
– Handles any amendments to registered products under responsibility.
2. Ensure the compliance of reporting adverse event/quality issue as regulation.
3. Ensure the compliance of relevant regulation of Ministry of Health and other concerned authorities
4. Coordinate with supply chain department to support for product’s availability on market.
5. Maintains awareness of changes to laws, regulations and requirements and keeps the other department managers informed of these changes as soon as possible
6. Provides professional comments, recommendations and requested information on legal documents to local and oversea colleagues.
7. Product Advertising and Promotional Material
– Provides regulatory comments/advice to Marketing staff in developing promotional materials and product advertising activities according to the relevant SOP.
– Support Marketing to follow-up with MOH/Hanoi SOH on advertising/promotional pieces for urgent issues.
8. Packaging Artwork Development
– Coordinate with AW/plant’s colleagues in developing the artwork for packaging materials of products in responsible portfolio.
9. Coordinate with Head Quarter and other partners when required.
10. Other projects assigned by Head of PEH Regulatory Affairs Vietnam.
Yêu Cầu Công Việc
– Minimum 3 year experience in Regulatory Affair function/ or Fresh Graduate.
- Fluent in English / French is an advantage
- Good Microsoft Office skills (Word, Excel, PowerPoint)
- Good communication & office administrative skills
- Competitive Salary
- Healthcare & Insurance as Labor Code
- Professional working environment