Regulatory Affairs Specialist

Datwylers high-tech elastomer components make a vital contribution to the safety reliability and functionality of critical systems in billions of syringes and coffee capsules in every second vehicle worldwide and in energy-related applications. Datwyler serves highly regulated and technologically demanding markets such as Healthcare Automotive Food & Beverage and Industry.
With around 7500 employees and 25 production sites on four continents we work closely with customers from concept to series production. Our employees are at the heart of Datwyler. Guided by Mastery Impact and Respect we continuously improve focus on meaningful results and collaborate with trust and openness.
Become part of our team as a Regulatory Affairs Specialist.

Job Purpose

The responsibility of the Regulatory Affairs Specialist 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 implementation of revised standards regarding CDS & COAs
Demonstrate 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

Skills & Technical Competences & Behaviors

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

Be yourself at Datwyler

People make the difference at Datwyler. We offer a wide range of career and development opportunities in an international company where you can contribute your skills ideas and experience. Together we create an environment where people can grow and help shape our future.