Regulatory Affairs Manager (all genders)

Midas Pharma

Ingelheim am Rhein

Your mission
• Regulatory advice and responsibility in relation to development and transfer projects with a focus on chemically defined active ingredients
• Evaluation of regulatory documents, including due diligence
• Conception, discussion and support in the implementation of regulatory strategies of projects (set-up, realization and lifecycle)
• Accompanying project management with focus on regulatory support (participation in external and internal meetings/teleconferences/visits)
• Preparation of regulatory documentation for active pharmaceutical ingredients with focus on quality documentation (CMC)
• Submission and support of national and international registration procedures for APIs (EU, USA, Brazil, China and other markets), especially for the Midas Own-API pipeline, incl. change notifications, deficiency letters, change control
• Maintenance, servicing, synchronization of national and international approvals in accordance with legislation, applicable guidelines and Midas... More Detail

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