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Regulatory Affairs Officer
vor 1 Monat
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Regulatory Affairs Officer (M/F), Lausanne DistrictClient:LHH
Location:Lausanne District
Job Category:Other
Job Reference:5efb760220c2
Job Views:8
Posted:03.03.2025
Expiry Date:17.04.2025
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:
- Regulatory Documentation: Prepare and compile regulatory documentation, and execute regulatory submissions with authorities like FDA, European Notified Bodies, Health Canada, etc.
- Data Review: Review analytical data from development and performance evaluation studies.
- Guidance: Advise staff and project teams on data and information required for successful license applications.
- Product Labelling: Develop regulatory requirements for product labelling and liaise with internal and external parties.
- Regulatory Watch: Maintain knowledge of new or updated regulatory requirements and industry standards.
- Compliance: Ensure maintenance of product regulatory documents and technical files to support compliance.
- Liaison: Liaise with regulatory authorities and external contract bodies.
- Product Development: Participate in product development projects to provide regulatory guidance.
- Quality System: Document changes in accordance with quality system requirements and communicate them to regulatory authorities.
- Training and Support: Provide support, guidance, and training to team members.
- Other Duties: Perform other duties as requested and ensure compliance with GMP, GDP, and other regulatory requirements.
Your Profile:
- Relevant degree and/or work experience in a regulatory affairs environment.
- Previous regulatory experience, knowledge of CE and FDA regulations, and experience in preparing and submitting regulatory documents.
- Ability to prepare regulatory reports, sound knowledge of IT packages, and experience with regulatory submissions.
- Team player with clear communication skills.
- Proactive and able to work independently or within a team.
- Attention to detail and ability to analyze information.
- Ability to work under pressure and manage workload effectively.
- Leadership skills and ability to build relationships with stakeholders.
