Tuyển dụng đăng ký thuốc Pfizer tháng 8/2017

Tuyển dụng đăng ký thuốc Pfizer tháng 8/2017
Tuyển dụng đăng ký thuốc Pfizer tháng 8/2017
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Tuyển dụng đăng ký thuốc Pfizer tháng 8/2017

VỊ TRÍ: Regulatory Affairs Associate


Position Purpose:
– 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.

– Bachelor of Pharmacy, graduated from Hanoi University of Pharmacy
– 2-3 years of experience in MNC in Regulatory
– Computer skill: Microsoft Word, Excel, Power Point, Adobe Illustrator, Adobe Photoshop
Tầng 12A tòa nhà Geleximco, số 36 Hoàng Cầu, , Quận Đống đa, Hà Nội
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Ngày viết:
Vietnam Regulatory Affairs Society. Join us, VNRAS, feel free to contact. We'll provide you all information and regulatory affairs update related to products covered by the Ministry of Health of Vietnam (drug, vaccine, biological, pharmaceutical raw material, excipient, capsule, traditional medicine, herbal medicine, medical equipment, invitro diagnostic medical devices, cosmetic, food supplements, chemical and preparation for medical and household use).
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