🙌🏻 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 www.menariniapac.com
💰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
- Business Development
- Sales & Marketing
- Project Management
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