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Regulatory Affairs Manager

Merck Vietnam

Center Point building Tầng 9, 106 Nguyen Van Troi, Phu Nhuan, HCMC
Từ 2.500 VNDKinh nghiệm chưa rõĐăng gần đâyNguồn: VietnamWorks
Ứng tuyển trên VietnamWorks

Tổng quan công việc

Report to: Head of RA Location: Ho Chi Minh city Your Roles:

Lead regulatory strategy for projects aligned with business objectives.

Own end-to-end portfolio: new MA, variations, extensions, site registration, tenders, promotional activities, biologics (innovator/reference), import licenses.

Provide expertise across chemical drugs, biologics, and medical devices.

Drive regulatory intelligence and policy advocacy. Your roles:

Develop and execute...

Kỹ năng chính

drug registrationeffective communicationmedical devicesregulatory strategyregulatory intelligence

Yêu cầu

Who You Are:

Bachelor of Pharmacy; Master’s degree preferred.

At least 8 years in Regulatory Affairs (Pharma), including at least 2 years at RA Manager level; experience with imported products and medical devices preferred.

Strong experience in innovative drug applications.

Able to independently manage drug registration dossiers with DAV and clinical trial submissions to...

Quyền lợi

Thưởng: 13 months, Year end bonus

Chăm sóc sức khoẻ: company provide your employee and your parrent.

Máy tính xách tay: company provided

Thông tin bổ sung

Tín hiệu vai trò

Y tế, Dược

Học vấn/chứng chỉ

Đại học, Thac Si