navigos search's client - a japanese company

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Quy mô công ty: Hơn 500 nhân viên

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Regulatory Affairs Manager (Pharma) - Salary Up to $2500 - Temporary Contract

Hạn nộp: 04-05-2019

Hình thức: Chưa cập nhật

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

Mô tả công việc

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.
4. Other
- To assist colleagues in supporting other business units or product portfolios, whenever necessary.

Yêu cầu công việc

- 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.

Quyền lợi được hưởng

- Competitive package
- Insurance
- Pay raise

Hồ sơ

Nội dung chưa cập nhật

Công việc gợi ý
Vị trí Regulatory Affairs Manager (Pharma) - Salary Up to $2500 - Temporary Contract làm tại Hà Nội đang được navigos search's client - a japanese company tuyển dụng với mức lương 1 triệu - 3 triệu.
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