For our customer located in Rotkreuz/Switzerland we are currently looking for a: Drug Regulatory Affairs Coordinator (m/f/d)
Gross Rate Range (given by client): 47-54,50 chf/h gross
Job Purpose:
Takes care of all drug regulatory affairs matters regarding the assigned indication group. Acts as an interface between global Regulatory Affairs departments and Swissmedic in order to obtain new marketing authorizations, support new product launches and ensure regulatory compliance.
Tasks & Responsibilities
- Preparation of the regulatory strategy for new submissions
- Timely submission of new products to Swissmedic in agreement with the yearly target
- Obtain a number of marketing authorizations in accordance with the yearly target
- Life cycle management. Submit maintenance variation packages to ensure regulatory compliance.
- Provide close regulatory support to the product launch work stream
- Strategic business partner to Business Development, Quality Assurance, Supply Chain as well as for other Global Regulatory Groups (RCCs, MRCs)
- Follow trends in the regulatory environment and legislation and assure awareness and alignment within the department, in order to meet future requirements on time
- always work in accordance with Good Regulatory Practice
Must Haves
- Education: Pharmacist or natural scientist preferably with medical background
- Languages: German (fluent), English (intermediate to advanced) and French (desirable)
- Experience: Intermediate (1-2 years Regulatory experience)
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.