Regulatory Affairs Consultant, German, French

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Create, contribute to, and review documentation and formatting for regulatory submissions in accordance with Swiss regulatory standards.

• Prepare and oversee both major and minor submissions, including PSURs, label modifications, CMC variations, post-approval commitments, variations, and notifications.

• Collaborate with Swiss regulatory authorities, Global Regulatory Science, Regulatory CMC, and cross-functional project teams to devise and implement regulatory strategies.

• Manage regulatory submission components for designated projects and programs.

• Maintain Swiss labeling, encompassing SmPC, PIL, artwork, and packaging in local languages.

• Operate both independently and as part of project teams to meet collective objectives.

• Assist the Head of Regulatory Affairs Switzerland with various regulatory tasks.

⛳️ Requirements

• A University Degree in Life Sciences or a related field.

• 5-8+ years of professional experience in Regulatory Affairs, specifically with Marketing Authorization Applications and post-approval variations.

• Comprehensive and up-to-date understanding of Swissmedic regulations (mandatory).

• Demonstrated experience in preparing significant regulatory submissions and variation packages for Swissmedic.

• Extensive expertise with CTD format and eCTD submission construction.

• Proficient in spoken and written German, French, and English.

• Experience in the development of biologics and vaccines is preferred.

• Familiarity with Rare Diseases, Autoimmune Diseases, or Oncology therapeutic areas is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance and wellness programs.

• Opportunities for professional development and training.

• Flexible working hours and remote work options.

• Collaborative and innovative work environment.