Regulatory Affairs Officer (M/F)LHH

The Adecco Group Switzerland

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 Responsabilities:

• 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.
• Available now or within 1 month.

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