Drug Regulatory Affairs Coordinator

vor 1 Woche

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**Drug Regulatory Affairs Coordinator**

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

We are looking for a **Drug Regulatory Affairs Coordinator** to take care of all drug regulatory affairs, within the assigned indication group. Acting 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. This is a contract role for a period of approximately 9 months.

**Main Responsibilities**:

- Preparing the regulatory strategy for new submissions
- Submitting of new products to Swissmedic in agreement with the yearly target
- Obtaining a number of marketing authorizations in accordance with the yearly target Life cycle management
- Submitting 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 (GRP)

**Qualifications and Experience**:

- **Relevant Swiss working/residency permit or Swiss/EU-Citizenship required**;
- Qualification of Pharmacist or natural scientist preferably with medical background
- German (fluent), English (intermediate to advanced) and French (desirable)
- Minimum of 2 years Regulatory experience

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