Beschreibung
EUROPEAN REGULATORY AFFAIRS - CTA MANAGERDuration: 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.