Assistant Manager - Regulatory Affairs

Role & responsibilities

• Responsible to assess customers requests for

  Letters of Authorization (LOA) to reference Drug Master Files (DMFs)

• Issue

  LOAs 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 implementation of revised standards (change control process)
• Demonstrate strong competence pertaining to

  regulatory knowledge like pharamcopoeial requirements (USP, EP, JP, ChP), regulatory guidelines issued by EU, USA, China, Canada, ICH & other health authorities

• Keep abreast with the new updates from Health Authorities like FDA warning letters, authorization of innovative products, etc.
• Provide regulatory support to Datwyler employees and customers
• Participate in different internal projects for regulatory support
• Update internal trainings for employees

Preferred candidate profile

• Master or Bachelor degree in a scientific discipline (chemistry, biochemistry, biomedical sciences, biology,...)

  plus 3 years of experience in Regulatory Affairs or R&D or QA/QC in pharmaceutical packaging components or pharmaceutical industry

• Willing to develop detailed

  regulatory knowledge about packaging components, specifically rubber but also aluminium

• Entertaining frequent internal contacts with colleagues in various departments (R&D, Sales, Quality, ..) and in various parts of the world (Europe, China, USA)
• Skilled in

  eCTD dossier preparation

  & technical writing
• Punctual in maintenance and storage of regulatory files and documents
• Partially working from home/office (after training period)
• Only sporadic traveling (less than 5 % of working time)
• Good spoken and written English