Regulatory Affairs Specialist

Datwyler; Satara; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Datwyler is seeking a Regulatory Affairs Specialist to support customers referencing Drug Master Files (DMFs) and manage LOA processes for multiple regulators. You will maintain data, prepare submission packages, and coordinate with QA, R&D, and sales teams across regions.

The role requires strong technical writing and regulatory knowledge. Partial remote work is possible after training, with occasional travel.

Qualifications

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Responsibilities

• Assess customer requests for Letters of Authorization to reference Drug Master Files (DMFs).
• Issue LOA drafts for US-FDA, Health Canada and NMPA China.
• Maintain LOA data base and share analyses with sales teams.
• Prepare weekly data packages for DMFs and support RA Manager for annual DMF reports.
• Ensure availability of annual washing validation reports and transform into submissions formats.
• Coordinate samples and testing data for submissions.
• Support RA Manager in dossier preparation and responses to Health Authorities.
• Manage notarization and legalization of quality certificates/documents.
• Maintain ISO database and assist staff with standards.
• Track standards updates and implement revised standards for CDS & COAs.
• Stay informed on regulatory guidelines from EU/USA/China/Canada/ICH.
• Provide regulatory support to employees and customers.
• Participate in internal projects for regulatory support.
• Update internal trainings for employees.

Skills

eCTD dossier preparation

Technical writing

English communication

Education

Master's degree in a scientific discipline

Bachelor's degree in a scientific discipline

Job description

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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...

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

We 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.