Assistant Manager- Regulatory Affairs

Khandala, Maharashtra
Permanent
Full-time

13 days ago

In billions of syringes and in every second car worldwide, Datwyler components make an important 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...Reporting & Interaction

Reports to: Manager Regulatory Affairs

Interacts with: Support global sales team; Pharmaceutical customers, Technical & Scientific Experts/Managers, T&I Material Managers & Labs, Agents for global Health Authorities, healthcare sites Validations Engineers, all Internal colleagues

Main Tasks & ResponsibilitiesResponsible 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

Skills & Technical Competences & Behaviors

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

Be yourself at DatwylerWe are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.

Dätwyler

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