European Regulatory Affairs - CTA Manager

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Beschreibung

EUROPEAN REGULATORY AFFAIRS - CTA MANAGER

Duration: 1 year initially

Location: Zug, Switzerland

Role and Responsibilities:

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.
  • Anticipate and bring solutions for potential regulatory risks.
  • Maintain good knowledge of regulatory requirements and guidelines.
  • Research relevant regulatory precedents to understand the regulatory landscape applicable to development programs.
  • 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.
  • Support the European Regulatory team as required.


Minimum Requirements
  • 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).


Competencies And Attributes
  • Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting.
  • Strong technical/analytical skills to identify and solve problems independently.
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
  • Willingness to work collaboratively and incorporate diverse perspectives into decision-making.
  • Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality.
  • Proven ability to manage multiple projects, identify and resolve regulatory issues.
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
  • Proactively seeks out and recommends process improvements
  • Ability to balance regulatory objectives with business objectives
  • Entrepreneurial, enjoys working in a fast-paced, small-company environment


Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
10/2022
Von
Real Staffing
Eingestellt
28.09.2022
Projekt-ID:
2470080
Vertragsart
Freiberuflich
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