Regulatory CMC Manager - Small MoleculeApply Now

About the Role

Key Responsibilities

• Execute Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions.
• Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
• Participates effectively in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Required Knowledge/Skills

Required Qualifications

• Ability to assess the CMC changes and how that impacts the greater team
• Required Knowledge/Skills
• Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
• Strong problem-solving skills and the ability to present the overall assessment for management alignment
• Ability to collaborate and communicate in an open, clear, complete and timely manner
• Required Education Level & Experience
• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field

Preferred Qualifications

• supporting Small Molecule programs

Key Skills

Compensation