Senior Associate / Associate Manager, Regulatory Affairs

• Coordinate CTAs, amendments, orphan drug applications, paediatric plans, and annual reports.
• Maintain product information and assess promotional materials.
• Collaborate with internal stakeholders to implement regulatory strategy.
• Assist in agency meeting preparation and briefing documents.
• Track queries and commitments with regulatory agencies, ensuring timely responses.
• Manage regulatory documents in internal systems, including submission tracking and archiving.

• 3-5 years of experience in a Regulatory Affairs capacity within the pharmaceutical industry.
• Demonstrated interaction with SwissMedic and solid understanding of Swiss regulatory requirements.
• Hands-on experience with CTAs and MAAs in Switzerland.
• Strong understanding of the drug development process.
• Excellent communication and planning skills, with a detail-oriented and proactive approach.

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