Company Description
Lotus, founded in 1966 and publicly traded as 1795: TT, is a global pharmaceutical company dedicated to providing novel and generic medicines that are safer, better, and more accessible. With a state-of-the-art R&D and manufacturing platform in Asia, Lotus has established partnerships in key global markets, including the U.S., Europe, Japan, China, and Brazil. The company manages over 100 pharmaceutical projects and offers a diversified portfolio, including high-barrier oncology drugs, complex generics, 505(b)2, and NCEs, strengthened by biosimilars.
Role Description
This position is based in Hanoi, Vietnam and is responsible for working with Global Regulatory Teams and head office-based team members to support RA function in the country.
Primary responsibilities of this role include but are not limited to:
- Responsible for all related regulatory activities in Vietnam from New filing to Lifecyle management activities
- Provides direction for the activities related with assigned products. Works with Global Regulatory Teams (GRT)and head office-based team members ( e.g. Artwork team )and to support the regional and local strategy for assigned products.
- Understands regional and local requirements and advises the Global Regulatory Team (GRT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.
- Provides inputs to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
- Responsible for communicating with the cross functional team and all the regulatory submission for Vietnam and submission dossier request has been submitted on the time
- Ensure internal regulatory database/ system is properly updated and maintained.
- Ensure that regulatory registration for Vietnam are submitted within company goal.
- Responsible for the status for on-going regulatory registration for Vietnam until Lotus received the approval.
- Ensure that all deficiency letters are properly and timely replied to have approved per the company goal.
- To provide regulatory pathway and resolve regulatory related query to the cross functional department.
- Responsible for review of artworks that are compliant with DAV requirements.
- Manages regulatory interactions with DAV.
Qualifications
- Bachelor's degree in pharmacy
- Proficiency in English
- 4+ years of relevant experience in regulatory affairs or pharmaceutical operations
- No disbarred from pharmaceutical operation
- Stronglogical and analytical thinking skills
- Strong computer skills
Demonstrated capabilities in:
- Analytical Thinking & Problem Solving
- Planning & Organizing
- Regulatory Strategy
- Project Management
- Influencing & Persuading Stakeholders
