Regulatory Affairs Specialist - International Markets

This is an exciting role for individuals with prior Regulatory experience in Food Supplement, Medical Devices and some knowledge of Cosmetics, who desire to enhance their career through International regulatory exposure and development. This role will build on an already established Regulatory career of 5 years of more experience.

Expectations will be set around maintaining product regulatory and technical dossiers for the international markets suitable for multiple regulatory agencies, from Asia Pacific, Europe, Middle East, South Asia and South America.

You will have well defined people skills and be able to negotiate with both internal teams, government agencies and regulatory consultants on getting the best results for our regulatory progression across international markets, e.g., be able to challenge the government agencies with their guidelines that are up to interpretation. Acting as a conduit between the R&D, Quality teams, International Team and manufacturing, to secure speed of compilation of our regulatory dossiers.

Having experience in Project management work will be advantageous to know how to properly structure your work and focus on delivering the best outcomes.

Responsibilities

• Support international regulatory agencies and LiveSpo International team in the classification of the LiveSpo range with international markets.
• Prepare registration dossiers for international countries; for classifications ranging from Food, Food Supplement, Health Supplement, Medical Device, Cosmetics.
• Maintain an active database of standard dossier requirements for each country as compared to Vietnam dossier requirements.
• Support submissions for Certificates of Free Sales
• Support International team of LiveSpo to close all correspondence pertaining to LiveSpo registration in international markets.
• Work with Research and Development and Quality teams in completing dossier information and additional testing needed for International markets.
• Act in advisory and support role for International teams when preparing product labels for international markets to find the allowable claims for each new country or the fastest market entry point without product claims.
• Attend update calls with International regulatory agencies.
• Key Measurement of success:
• Successful product dossier submission to international markets, based on KPI target.
• Successful product registration based on KPI target in international markets.
• Developing a smooth project management approach amongst internal teams that reduces internal wait time each year for product dossier preparation submissions to international markets.

Requirements

• Bachelor’s degree in scientific courses such as Pharmacy, Food Science, Formulation science, Biotechnology, Microbiology.
• At least 5 years’ experience in regulatory affairs in Vietnam across multiple segments including Food Supplement and Medical Devices as an example.
• Ability to demonstrate negotiation skills, problem solve and project management skills will be required.
• Attention to detail and ability to maintain active project work and databases for regulatory requirements on international markets.
• Some experience in ASEAN markets or beyond is advantageous but not essential as training and support will be provided.
• Fluent Spoken and written English is a must.

Benefits

Hiring manager: R&D Director

Location

Prefer HCM or Hanoi but not mandatory/ can be remote; Suggest having at least monthly meetings with R&D, Quality, Production and International teams.

Recruitment process

• 1st round: Ms. Ngoc Trang - Head of Talent Acquisition at Mekong Capital and Ms. Minh Hong - HR Director
• 2nd round: Mr. John - Group CEP and Dr. Van Anh - R&D Director

Apply now

Email: tuyendung@livespo.com | Website: https://www.livespo.vn

Fanpage: https://www.facebook.com/tuyendunglivespo