Regional Regulatory Lead (m/f/d)

Ihre Aufgaben:
• Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries
• Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements
• Communicate effectively to ensure that dossiers meet regional and local content and format requirements
• Coordinate, compile and track high-quality documentation for submissions, including new license applications and lifecycle activities to enhance connectivity and improve submission and approval timelines. This also involves addressing questions related to regulatory submissions
• Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes
• Collaborate with internal functions e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs to enhance connectivity
• Stay informed about international legislation and guidelines for biological products and related initiatives e.g., rare diseases, orphan drugs

Ihre Qualifikationen:
• A degree in Life Sciences, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
• Regulatory experience within the international region, supported by additional pharmaceutical /industry experience
• Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP and GCP
• Proficiency in standard regulatory tools : Veeva, DocNet, Trackwise

Ihre Vorteile:
• A very renowned company
• A highly motivated team and an open way of communication

Projektdauer: 12 MM


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