Regulatory Affairs Executive
Salary VND25,000,000 - VND35,000,000 per month + Attractive Incentive
Consultant Hanh Dinh (Ella)
Date posted 13 August 2018 2018-08-13pharmaceuticals 235 Dong Khoi Street District 1 Ho Chi Minh City Robert Walters Vietnam
An exciting Regulatory Affairs Executive job has just become available in one of the fastest growing pharmaceutical companies in the South-East Asia and South Korea (SEASK) region.
About the Regulatory Affairs Executive Role:
The main role is to achieve timely and successful product registrations in accordance with Corporate, Regional and Local strategies and maintain the regulatory position of registered/ marketed products in Vietnam, Myanmar and Cambodia.
- Review and update all the regulations from the authority, implement and comply with corporate procedures, processes and systems as applicable to these activities
- Cooperate with marketing and logistics to ensure smooth operations
- Prepare registration dossiers products as local regulations and company policies
- Submit registration dossiers to MoH of Vietnam, Myanmar and Cambodia as time manner
- Monitor the progress of the assessment with DKSH Myanmar and Cambodia, and coordinate with ROPU and corporate to achieve products licenses as the plan
- Perform maintenance activities depending on local or regional requirements such as variation on CCDS or CMC, renewal of MAA in Vietnam, Myanmar and Cambodia
- Involve in CPD 3, SLCI system and other relevant system
- Regulatory Compliance to ensure local implementation and compliance with Corporate Policies, Processes, Procedures and Guidelines relevant to DRA activities
- Pharmacist/ doctor focus on Regulatory Affairs
- Fluent in English include reading, writing, listening
- Good person in nature (can work in high pressure, enthusiasm, careful, have innovation, trust, integrity, honest…)
- Regulatory Affairs experience is at least for 1 year in MNC
- Well understand regulation and have good communication, analysis, and organisational skill
This pharmaceutical company needs no introduction and is recognised as the leader in their field of expertise. The firm takes employees’ development seriously and is committed to helping the employees to grow through extensive development programs, career opportunities in a diverse and inclusive working environment.
If you are focused Regulatory Affairs professional seeking the right opportunity to take your career forward, Regulatory Affairs Executive job is the role for you. You will be a part of a forward-thinking company that values innovation and a progressive mindset.