Regulatory Affairs Officer/specialist

5 hours ago

Hà Nội, Vietnam Servier (Vietnam) Pharmaceutical Company Full time

**Mô tả công việc**:
(Mức lương: Thỏa thuận)
Role Expectations

The Regulatory Affairs Officer/Specialist is expected to ensure full regulatory compliance and timely product registration in alignment with local and global strategies. They need to proactively monitor regulatory changes, propose proper solutions, maintain effective communication with authorities and strong cross-functional collaboration to support business.

Main Responsibilities
- Prepare, review, and submit oncology and other drug registration dossiers in compliance with Vietnamese regulations.
- Coordinate with cross-functional teams (Worldwide & regional RA, manufacturers and other departments).
- Keep updated with the latest pharmaceutical regulations in Vietnam and guidelines.
- Ensure compliance with national and industry-specific regulations. Interpret new rules and implement them throughout the company by updating policies and procedures.
- Handle post-approval activities such as renewal, variation, and dossier updates.

**Chức vụ**: Nhân Viên/Chuyên Viên

**Hình thức làm việc**: Toàn thời gian

**Quyền lợi được hưởng**:
Lương cạnh tranh, lộ trình thăng tiến rõ ràng..
Đào tạo bài bản về nghiệp vụ, kĩ năng, sản phẩm và các kĩ năng khác phục vụ công việc. Tham gia các khoá đào tạo và dự các kỳ họp toàn công ty trong và ngoài nước (Cycle meeting, NC,...)
Year-end party, Câu lạc bộ bóng đá, cầu lông, và các chương trình internal cực kì hấp dẫn khác

**Yêu cầu bằng cấp (tối thiểu)**: Đại Học

**Yêu cầu công việc**:
Educational & Professional Background
- Bachelor’s degree in Pharmacy
- Solid knowledge of Vietnamese pharmaceutical regulations (Law on Pharmacy, Decree, Circulars)
- Proficiency in preparing and reviewing CTD dossiers (Common Technical Document).
- Familiarity with working with the Drug Administration of Vietnam (DAV), Ministry of Health, and relevant authorities
- Sufficient knowledge of oncology drugs to ensure the quality of regulatory submissions.

Hard Skills
- Experience in dossier preparation for originators
- Strong ability to read and interpret scientific and regulatory documents in English.
- Minimum 5 years of experience in regulatory affairs or drug registration and especially, oncology.

Soft Skills
- Attention to detail, accuracy, and good time management.
- Effective communication skills to liaise with regulatory bodies and international partners.
- Proficiency in regulatory submission internal data system, software and tools.

Other
- Ability to work with complex scientific documents (clinical data, CDx, pharmacokinetics).
- Capable of working independently as well as in a team environment.

**Yêu cầu giới tính**: Nam/Nữ

**Ngành nghề**: Dịch Vụ Khách Hàng,Quản Lý Dự Án IT,Quản Lý Thành Công Khách Hàng

Đại Học
Không yêu cầu

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