Pharmaceutical & Medical Services
09 Aug 2018
Job Opportunity : Regulatory Affairs Manager - Indochina(90-140K)
Position
Regulatory Affairs Manager - Indochina(90-140K)
Our Client
A leading international healthcare company
Responsibilities :
- Ensure timely submissions and approvals of applications according to regulatory plan, reviewing it periodically, coordinate approval dates with key stakeholders and 3rd-party service providers.
- Ensure timely submissions of post-approval commitments.
- Communicate with FDA and provide appropriate answers to requests from FDA.
- Ensure alignment of registered details with original dossiers and corporate databases, timely update of the corporate databases.
- Identify possible regulatory issues, proactively communicate and escalate them, provide feasible solutions.
- Identify areas of opportunities and risks related to regulatory activities and company in general.
- Provide support to local procedures development and update.
- Implement and comply with QMS requirements in the following processes: management monitoring, deviation handling, CAPA management.
- Ensure regulatory support to GMP inspections if required.
- Ensure compliance with regulations and company’s policies/ guidance/ SOPs
Qualifications:
- Bachelor’s degree or equivalent in pharmacy, biology or chemistry.
- Experience in Regulatory Affairs and knowledge of pharmaceutical regulatory requirements in at least one of the country is the advantage.
- Good command of English.
- Ability to work within diverse cultures, possess high degree of comfort and positive engagement working as a member of a multifunctional or multicultural teams.
- Good management and project leadership skills, ability to provide advice and counsel to company staff in strategic decisions