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You will directly assist the Business Development Director in meeting the strategic, scientific, therapeutic, and commercial needs of MPP. The role contributes to shaping MPP business development strategy through the in...
The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.
Ensure efficient, compliant and timely management of CPP (Certificate of Pharmaceutical Product) submissions and legalization activities as central coordinating function within GRA; Provide transparent tracking, prioritization and status of workflows
Planning, preparation, submission and support of regulatory applications in EU for designated projects/products in different therapeutic areas, including new Marketing Authorization applications, line extensions, variations, clinical trial applications,
Leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas. This role involves