Associate Director Regulatory CMC (m/f/d)

Zürich  ‐ Vor Ort
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Beschreibung



Associate Director Regulatory CMC (m/f/d)

Reference: -en
Start: 01/22
Duration: 12 MM

Main tasks:
  • Assessing and confirming the High Level impact assessment performed by Global CMC lead
  • Responsible for assessing the CMC change impact to SmPC/PIL/labelling
  • Provide direction to senior leadership, as relevant
  • Develops and maintains effective working relationships with Global Regulatory Teams, Cross-functional Teams; consultants and business partners as required
  • Final regulatory impact assessment for the CMC changes in EU
  • Manage, plan, and execute regional CMC regulatory submissions within the area of responsibility and ensure timely approvals throughout product development and lifecycle
  • Lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products
  • Identifies regulatory requirements across area of responsibility, and provides regulatory guidance, and expertise to global development team and /or higher governance bodies in these areas
  • Presents regional regulatory strategies to senior management as applicable


Main qualifications
  • BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
  • Experience within the pharmaceutical industry and including direct experience in CMC regulatory affairs in development and post-marketing phases for medicinal products
  • Experience in Medical Device regulation as an advantage
  • Experience in CMC regulatory affairs for biological/biotechnological products as an advantage
  • Strong expertise in the EU region: CMC lifecycle maintenance, Variation Regulation/Guideline; preferred experience in managing multiple filings; or managing multiple programs in closely related development area
  • Willingness to travel to various meetings, including overnight trips


Main advantages:
  • A very renowned company



About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

My contact at Hays:

My contact person:
Marc Peter Linder

Referencenumber:


Make contact:
Email:
Start
01/22
Dauer
12 MM
Von
Hays AG
Eingestellt
17.12.2021
Ansprechpartner:
Hays AG
Projekt-ID:
2277041
Vertragsart
Freiberuflich
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