Regulatory Affairs Specialist

Datwyler Group; Satara; Hybrid; INR 7,648,000 - 11,472,000; Full time

Job summary

Datwyler is seeking a Regulatory Affairs Specialist to support LOA references to Drug Master Files, facilitate washing validations and ensure provision of standards across global sites.

You will assess LOA requests, draft LOAs for FDA/Health Canada/NMPA, maintain databases and prepare data packages for DMFs, while collaborating with R&D, QA and Sales teams worldwide. Occasional travel and home‑office flexibility after training are expected.

Qualifications

• Master or Bachelor degree in a scientific discipline with 3+ years in Regulatory Affairs or QA/QC.
• Willing to develop regulatory knowledge about packaging components (rubber/aluminium).
• Frequent internal collaboration with R&D, Sales, Quality across regions (Europe, China, USA).
• Skilled in eCTD dossier preparation and technical writing.

Responsibilities

• Assess LOA requests to reference Drug Master Files (DMFs).
• Draft LOAs for US-FDA, Health Canada and NMPA China.
• Maintain LOA database and share analyses with sales teams.
• Prepare weekly DMF data packages and support annual DMF reports.
• Verify annual washing validation reports for healthcare sites and convert to submission formats.
• Arrange samples and testing data for submissions.
• Support dossier preparation and responses to Health Authorities.
• Manage notarization and legalization of quality certificates/documents.
• Maintain ISO database and assist in obtaining working copies of standards.
• Track standards updates and implement revised CDS & COAs.

Skills

Regulatory knowledge

eCTD dossier preparation

English proficiency

Cross‑functional collaboration

Documentation maintenance

Travel flexibility

Education

Master or Bachelor in a scientific discipline

+3 years Regulatory Affairs/QA/QC

Job description

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.

www.datwyler.com