Regulatory Affairs Specialist Job in Switzerland

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Regulatory Affairs Specialist Job Description

Pauwels Consulting is currently looking for a Regulatory Affairs Specialist for our pharmaceutical partner in Switzerland.


The main responsibilities of the Regulatory Affairs Specialist are:
 

• Responsible for planning, preparation, submission and maintenance of country-specific dossiers (EU, Latin America, Middle East, Asia, Africa).
• Maintains a global overview on product-specific activities and coordinates these activities.
• Track regulatory status of the submissions and approvals in the countries (new submissions, variations, etc.).
• Creates, reviews, corrects, releases and archives printing material.
• Works according to global regulatory management system.
• Supports the establishment of all relevant documentation in the document management system.
• Being an interface between marketing, quality, production, company subsidiaries and partner companies.
• Good quality and timely submission of regulatory documentation is a key to establish reliable access to the product markets.

Regulatory Affairs Specialist Job Requirements

What does Pauwels Consulting require from the Regulatory Affairs Specialist:
 

• Scientific degree in natural science or equivalent.
• At least two years of working experience in the RA field, preferably, with a focus on vaccines, biologics or pharmaceuticals.
• Knowledge of regulatory procedures and requirements.
• Experience with Asian and Latin American regulations is desirable.
• Experience with electronic document management systems, including eCTD creation, is desirable.
• Good communications skills (written and oral).
• Fluency in oral and written English is required, German is desired.

Regulatory Affairs Specialist Application Information

What can you expect from Pauwels Consulting.

A responsible position in a leading international company.
Personal development opportunity’s through learning on the job and additional external trainings.
You can expect a market oriented compensation, including a wide range of fringe benefits


Please apply with your CV and cover letter by the 'apply' button below

Regulatory Affairs Specialist Summary

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