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ID: POS06069

European Regulatory Affairs - CTA Manager (m/f/d)

Pharma & Biotech
January 2023
12 months
Zug
K-Recruiting Schweiz AG
Contact:

Gelila Lulu

+49 89 1890998-632

gelila.lulu@k-recruiting.com

One of our Pharma clients in Switzerland is currently looking for support as:

European Regulatory Affairs - CTA Manager (M/W/D)
 
Tasks:

  • Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives.
  • Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments in the Europe (EU, UK and Switzerland). Support for rest-of-the-world clinical trial applications may be required
  • Contribute to the regulatory strategy by bringing the European insights into discussions
  • Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for development medicinal products
  • Work with regulatory affairs consultants/service providers on CTA submissions
  • Represent EU Regulatory Affairs at cross-functional study management team meetings
  • Research relevant regulatory precedents to understand the regulatory landscape
  • Communicate and educate cross-functional teams on European regulatory requirements and changes in the regulatory landscape
  • Participate in process improvement initiatives as required
  • Maintain an effective archiving and submissions/approvals tracking records

 Qualification:

  • Minimum of 4 years of experience managing regulatory submissions, with a primary focus on clinical trial applications and associated tasks.
  • BSc; MSc or PhD in a life sciences discipline.
  • Fluent in English (written and spoken).
  • Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union, Switzerland and United Kingdom. Experience with the new Clinical Trial Regulation would be an advantage.
  • Knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage).

Requirements:

  • Start: 01.12.2022
  • Duration: 30.11.2023
  • Capacity: 5 days per week
  • Location: Zug, Switzerland 
Have we aroused your interest? Let's go
Contact
Gelila Lulu
+49 89 1890998-632
gelila.lulu@k-recruiting.com