Qualification:
· Bachelor degree in Pharmacy, Chemistry or any equivalent background
· Having experience minimum 5 year in Quality Assurance or Regulatory at Pharmaceutical Company
· Having knowledge related to product registration process and regulation, quality control and manufacturing
· Team player and able to communicate with related departments and/or third parties
· Proficient in English
· Willing to be placed in Cikarang
Job Description:
· In collaboration with involved Manufacturing functions and Regulatory Affairs, responsible for preparing registration dossiers for products marketed.
· Responsible for supporting Regulatory Affairs for new Registrations, variation and MAH renewal related to the Chemistry, Manufacturing and Controls of the product throughout its initial development and lifecycle.
· Proposing technical solutions to address regulatory requirements or deficiency letter from health authority.
· Responsible for evaluating Dossiers, classifying any non-conformities found and coordinating the activities of drafting the documentation in requesting the execution of operational activities (e.g. stability studies, method development and validation, process validation, etc.).
· Responsible for verifying of technical document to ensure compliance with standard (e.g ACTD, ICH, etc) as well as alignment with corporate or regional document.
· Responsible for managing Change Control for regulatory topics as Originator (management of regulatory impact due to change on API Supplier, Site Change etc.)
· Maintaining effective relationships with local & global partners, i.e., Product Development, Quality Assurance, Regulatory Affair, other related functions.
· Support site project by providing a correct and timely registration dossier