Drug Regulatory Affairs Manager

vor 2 Wochen

Zug, Schweiz nemensis ag Vollzeit

At nemensis ag, we have connected thousands of applicants with their dream job and given them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Rotkreuz, we are looking for a Drug Regulatory Affairs Manager.

**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.
**Your 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
**Your profile**:

- Pharmacist or natural scientist preferably with medical background
- German (fluent), English (intermediate to advanced) and French (desirable)
- Intermediate (1-2 years Regulatory experience)

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