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Job ID: 12073

Senior Regulatory Affairs Manager (f/m)

Working for a privately owned internationally operating Life Science company in the region of Basel, Switzerland, specialized in the development, manufacturing and commercialization of analytical reference standards and pharmaceuticals for the treatment of rare diseases, particularly cancer.

Stellenart.

Festanstellung

Ihre Aufgaben.

  • Definition and implementation of regulatory strategies to expand the company’s 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.

Ihr Anforderungsprofil.

  • University degree (PhD, MSc) in Life Sciences, Pharmaceutical or Medical Sciences.
  • Minimum of 3 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.

Vorteile.

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Gehalt.

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