CMC Regulatory Staff

CMC Regulatory Staff

Qualification:

· Bachelor degree in Pharmacy, Chemistry or any equivalent background

· Having experience minimum 1 year in managing technical dossier at Pharmaceutical Company

· Strong knowledge in quality control, manufacturing, product development and regulatory

· Team player and able to communicate with related departments and/or third parties

· Proficiency in English is an advantage

· Willing to be hired under third party (outsourcing)

· Placement in Cikarang Selatan

Job Description:

· In collaboration with involved Manufacturing functions and Regulatory Affairs, responsible for preparing registration dossiers for products marketed.

· 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.

· Assist in 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.).

· Verifying of technical document to ensure compliance with standard (e.g ACTD, ICH, etc) as well as alignment with corporate or regional document.

· 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.