Regulatory Affairs Officer (M/F), Lausanne
Client:
LHH
Location:
Lausanne
Job Category:
Other
Job Reference:
5efb760220c2
Job Views:
3
Posted:
17.02.2025
Expiry Date:
03.04.2025
Job Description:
For one of our clients, a global leader in biotechnology based between Geneva and Lausanne, we are looking for a Regulatory Affairs Officer (M/F).
As part of a 9-month project and the launch of a product in the biotechnology market, we are looking for a candidate available immediately (within 1 month maximum). There are possibilities to continue on a permanent contract.
Your Responsibilities:
1. Regulatory Documentation: Prepare and compile regulatory documentation, and execute regulatory submissions with authorities like FDA, European Notified Bodies, Health Canada, etc.
2. Data Review: Review analytical data from development and performance evaluation studies.
3. Guidance: Advise staff and project teams on data and information required for successful license applications.
4. Product Labelling: Develop regulatory requirements for product labelling and liaise with internal and external parties.
5. Regulatory Watch: Maintain knowledge of new or updated regulatory requirements and industry standards.
6. Compliance: Ensure maintenance of product regulatory documents and technical files to support compliance.
7. Liaison: Liaise with regulatory authorities and external contract bodies.
8. Product Development: Participate in product development projects to provide regulatory guidance.
9. Quality System: Document changes in accordance with quality system requirements and communicate them to regulatory authorities.
10. Training and Support: Provide support, guidance, and training to team members.
11. Other Duties: Perform other duties as requested and ensure compliance with GMP, GDP, and other regulatory requirements.
Your Profile:
1. Relevant degree and/or work experience in a regulatory affairs environment.
2. Previous regulatory experience, knowledge of CE and FDA regulations, and experience in preparing and submitting regulatory documents.
3. Ability to prepare regulatory reports, sound knowledge of IT packages, and experience with regulatory submissions.
4. Team player with clear communication skills.
5. Proactive and able to work independently or within a team.
6. Attention to detail and ability to analyze information.
7. Ability to work under pressure and manage workload effectively.
8. Leadership skills and ability to build relationships with stakeholders.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
#J-18808-Ljbffr