Senior Regulatory Manager m/f/d (100%).

Job ID: 11436

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Type of employment
Festanstellung
Company

We are management consultancy. We are personnel consultancy. We are specialized. On Life Sciences. On Pharma. On MedTec. On LabMed. We work in DACH. In Munich. In Basel. We recognize motives. With candidates. We recognize needs. With clients. We bring people and organizations together. In permanent employment. In projects. In consulting scenarios.

Responsibilities
  • Definition and implementation of regulatory strategies to expand the clients 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.
Requirements
  • 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.
Region
Schweiz