Regulatory CMC Manager - Small Molecule (Contract)

Job Description The Chemistry Manufacturing Controls Manager will be responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams. Key Duties and 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 Strong interpersonal skills to exchange complex information with others and to guide others 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, clea