???? About Us Menarini is the world's largest Italian biopharmaceutical company with a heritage of over 135 years, and more than 16,000 employees in over 100 countries. Here in Asia-Pacific, Menarini's vision is to be a leading provider of important healthcare brands to improve the lives of people in the region. Menarini Asia-Pacific operates across the entire commercial value chain, from regulatory approval and product launch to lifecycle management with a diverse portfolio of proprietary and partnered brands in key therapeutic fields, including Dermatology, Select Specialty Care, Allergy/Respiratory, Cardiovascular, Men's Health and Consumer Health. For more information about Menarini Asia-Pacific, please visit
?? Salary Very competitive
?? Job Role 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 ?? Requirements Bachelor degree in Pharmacy, Chemistry or any equivalent background Having experience minimum 1 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 ?? Perks Competitive Salary Medical Insurance THR / Bonus system
