Địa chỉ: Chưa cập nhật
Quy mô công ty: Hơn 500 nhân viên
Website: Chưa cập nhật
Email: Đăng nhập để xem
Hạn nộp: 04-05-2019
Hình thức: Toàn thời gian cố định
Kinh nghiệm: Không yêu cầu kinh nghiệm
Số lượng tuyển: 0
Nơi làm việc: Hà Nội,
Ngành Nghề: Hành chính - Văn phòng
Bằng cấp: Không yêu cầu bằng cấp
Mức lương : 1 triệu - 3 triệu
1. Product Registration
- To ensure the proper submission of NDA of new products to the health authority (DAV), including but not limited to, compilation of regulatory dossiers and preparation of product information (e.g., package insert and artwork of package materials).
- To ensure accurate reporting and compliance to the regulatory requirements.
- To liaise, clarify and negotiate with DAV and respond to queries raised by DAV to obtain Marketing Authorizations (MA).
- To coordinate with our group companies, including those in Singapore and Japan (and third party partners as the case may be) to obtain the necessary documents and update submission / registration timeline for regulatory dossier submission.
- To be responsible for all regulatory affairs, including but not limited to NDAs, new indications, variations and registration renewals.
2. Regulatory Input
- To search, collect, analyze and evaluate the information regarding regulations and other surrounding environment with respect to regulatory activities, and make and send the report for them.
- To visit regulatory authorities (e.g., DAV), important medical consultants and key customers in the public and private sectors, when necessary.
- To contribute RA inputs (e.g., regulatory strategies, timelines, labelling change, stock impact during transition period, etc.) for ad-hoc projects such as assessment of new in-license products.
3. Preparation for Future Operation (Import License, PV/QA)
- To prepare an application for any license required for a pharma company to import and/or sale of pharmaceutical products, when becoming necessary, and to be the Responsible Person named in such license.
- To develop and manage the pharmacovigilance scheme that conform to the local and global regulatory requirement, including but not limited to, preparing the local Drug Safety SOPs and Pharmacovigilance Agreement with third parties (e.g., distributor) to ensure appropriate collecting and reporting safety procedures are in place.
- To prepare the necessary SOPs and other quality system that conforms to the local and global regulatory requirement with respect to product quality and GDP.
- To assist colleagues in supporting other business units or product portfolios, whenever necessary.
- Registered pharmacist
- English speaking & writing skill
- More than 10 years of career in pharma company
- More than 5 years of experience in regulatory affairs function
- Experience of NDA submission and registration for multiple products.
- Competitive package
- Pay raise
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