In billions of syringes and in every second car worldwide, Datwyler components make an significant contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...
Job Purpose
The responsibility of the Assistant Manager Regulatory Affairs is to support customers’ requests regarding referencing of Datwyler Drug Master Files for drug approvals, facilitate washing validations, ensure provision of standards, etc.
Main Tasks & Responsibilities




• Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs)• Issue LOA drafts for US-FDA, Health Canada and NMPA China. • Maintain LOA data base, prepare analysis and share with the sales teams as required• Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs• Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats.• Arrange samples and testing data required for submission• Support RA Manager in preparation of dossiers and preparing response to the Health Authorities• Manage timely notarization and legalization of quality certificates/ documents • Maintain ISO database & support Datwyler employees in obtaining working copies of standards• Track list of standards for updates / revisions & support implement

📌 Regulatory Affairs Specialist (India)
🏢 Dätwyler
📍 India