Regulatory Affairs Officer/Specialist

2 weeks ago

Hanoi, Hanoi, Vietnam SERVIER Full time ₫900,000 - ₫1,200,000 per year

Date posted: Oct 13, 2025

City: Ha Noi

Country/Region: VN

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 10096

Regulatory Affairs Officer/Specialist

.

Job Description

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.
  • Monitor dossier progress, respond to inquiries, and prepare justifications for authority requests to ensure timely and accurate submissions of new drug applications, amendments, supplements
  • 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.

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 requirements:

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

Candidate Profile

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

  • Regulatory Affairs Officer/Specialist

    2 weeks ago

    Hanoi, Hanoi, Vietnam SERVIER MONDE Full time ₫6,000,000 - ₫12,000,000 per year

    . Job Description Role ExpectationsThe 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...

  • Regulatory Affairs Specialist

    1 week ago

    Hanoi, Hanoi, Vietnam Dr Reddy's Laboratories Limited Full time ₫6,000,000 - ₫12,000,000 per year

    Company Description At Dr Reddy's "Good Health Can't Wait"By joining Dr Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking...

  • Regulatory Affairs Specialist

    1 week ago

    Hanoi, Hanoi, Vietnam Dr Reddy's Laboratories Limited Full time ₫60,000,000 - ₫120,000,000 per year

    Company Description At Dr Reddy's "Good Health Can't Wait"By joining Dr Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking...

  • Regulatory Affairs Specialist

    1 week ago

    Hanoi, Hanoi, Vietnam Dr. Reddy's Laboratories Full time ₫4,000,000 - ₫8,000,000 per year

    At Dr Reddy's "Good Health Can't Wait"By joining Dr Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic...

  • Regulatory Affairs Oncology Manager

    1 week ago

    Hanoi, Hanoi, Vietnam SERVIER Full time ₫2,000,000 - ₫4,000,000 per year

    Date posted: Nov 21, 2025City: Ha Noi CityCountry/Region: VNType of Contract: Full-time Employment / UnlimitedJob Requisition ID: 10369Regulatory Affairs Oncology Manager.Job DescriptionRole ExpectationsThe Regulatory Affairs oncology manager is expected to ensure full regulatory compliance and timely product registration of Oncology products in alignment...

  • Regulatory Affairs Specialist

    5 days ago

    Hanoi, Hanoi, Vietnam Medtronic Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeResponsibilities may include the following and other duties may be assigned:Directs or performs...

  • Regulatory Affairs Specialist

    7 days ago

    Hanoi, Hanoi, Vietnam Gata Global Full time ₫252,000,000 - ₫504,000,000 per year

    Công tyCông ty 100% vốn Nhật, hoạt động trong lĩnh vực nhập khẩu và phân phối sản phẩm sữa, dinh dưỡng và chăm sóc sức khỏe. Thành lập tại Việt Nam từ năm 2021, quy mô khoảng 30 nhân sự, môi trường làm việc chuyên nghiệp, theo tiêu chuẩn Nhật Bản.Mô tả công việcThực hiện thủ...

  • Government Affairs Manager

    3 days ago

    Hanoi, Hanoi, Vietnam HP Full time $60,000 - $120,000 per year

    HP Inc. is seeking to recruit a Government Affairs Manager to drive policy issues affecting HP and the technology industry. The position will be responsible for developing strategies and influencing policies that present opportunities or risks for the company, particularly as it relates to supply chain and operations for the region.This position is a member...

  • Product Regulatory Specialist

    5 days ago

    Hanoi, Hanoi, Vietnam Nu Skin Full time $80,000 - $120,000 per year

    Regulatory assessment for new products i.e. claims, formula, labels.Prepare the registration documents, and follow up the registration of functional foods, skincare products.Artwork review and labeling compliance.Support Marketing to review the print aids and get the advertising licenses from Vietnam Food Administration & Ministry of Health.Support the...

  • Product Regulatory Specialist

    1 day ago

    Hanoi, Hanoi, Vietnam Nu Skin Full time $32,000 - $64,000 per year

    Regulatory assessment for new products i.e. claims, formula, labels.Prepare the registration documents, and follow up the registration of functional foods, skincare products.Artwork review and labeling compliance.Support Marketing to review the print aids and get the advertising licenses from Vietnam Food Administration & Ministry of Health.Support the...