Mine B.

Regulatory Strategy and Cmc Manager (Eu, Us) @HELM AG

Hamburg, DE

Contribute to the project-specific development strategy.• Responsible for the dossier compilation (Module 2- 5) including guidance and review of dossiers from external partners.• Develop solution proposals on topics of pharmaceutical quality in the assigned projects as well as general project-related interface coordination with clinical development management and Licensing.• Coordinate, participate and assist authority guidance requests (Scientific Advice Procedures, Controlled Correspondence etc.)• Communicate, coordinate, and negotiate with national competent authorities, internal and external partners, contract institutions, consultants and clients on quality and regulatory issues.• Assess data and market exclusivity and develop the initial approval strategy for assigned project ideas and projects.• Evaluate regulatory documentation on pharmaceutical quality within the scope of regulatory dossier purchases and in-licensing (Due Diligence)

İstanbul Teknik Üniversitesi

Master of Science (M.Sc.), Polymer Science and Technology

İstanbul Teknik Üniversitesi

Bachelor of Science (B.Sc.), Chemistry