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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