CMC Regulatory Officer

🙌🏻 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