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Senior Regulatory Affairs Manager (f/m)

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LIPOMED is a privately owned internationally operating Life Science Company headquartered in Arlesheim (BL), Switzerland, specialized in the development, manufacturing and commercialization of analytical reference standards and pharmaceuticals for the treatment of rare diseases, particularly cancer.

We are currently looking for an experienced

Senior Regulatory Affairs Manager (f/m)

In this position you will be responsible for the regulatory affairs activities in EU, CH and ROW and will lead a small team (3 direct report). Based in Arlesheim, you will report to the Chief Scientific Officer.

Your tasks:

  • Definition and implementation of regulatory strategies to expand the Lipomed portfolio and territories.
  • Preparation and submission of marketing authorization applications in Europe (DCP/MRP/ CP), Switzerland, and in other countries with support of local partners.
  • Life cycle management and maintenance of product approvals (renewals/variations/FUMs) worldwide.
  • Supervision of legal requirements and regulatory records to ensure proper traceability of regulatory history and of actual regulatory status.
  • Cooperation with other departments (internal and external stakeholders) to align timelines and regulatory strategies.
  • Participation and active contribution in meetings with partners and authorities.
  • Team lead: supervision and development of the regulatory staff, definition and assignment of projects and responsibilities, education and performance evaluation.

Your profile:

  • University degree (PhD, MSc) in Life Sciences, Pharmaceutical or Medical Sciences.
  • Minimum of 5 years of experience in hands-on working in Regulatory Affairs in EU and preferably other regions.
  • Strong communication and negotiation skills.
  • Strategic thinking and solution-oriented work approach.
  • Experience in people management and development, leadership skills.
  • Team player with customer-oriented behavior.
  • Ability to coordinate and network with various stakeholders simultaneously.
  • Fluency in German and English in writing and speaking; French knowledge advantageous.
  • Experience in CMC writing advantageous.
  • Experience in market access and pricing advantageous.
  • Good knowledge of MS-Office.

If you feel attracted by this responsible position please forward your application and curriculum vitae electronically to: shpetim.abduli@lipomed.com

Adresse

Lipomed AG
Herr Shpetim Abduli
Finanzen / HR
Fabrikmattenweg 4
4144 Arlesheim
+41 79 123 13 13

Site web http://www.lipomed.com

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