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If you're experienced in pharmaceutical formulations or chemistry manufacturing and controls, but you're interested in taking your career into a non-lab, regulatory affairs space, this is a great opportunity for a career pivot! The position leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions. It takes a proactive role in the critical review of molecule specific GRA-CMC development strategies and submission content. The role involves making technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists. The position also requires providing high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisions and evaluating regulatory impact on proposed CMC development plans. Effective communication, both verbally and in writing, is essential to influence within GRA-CMC and with the CMC development team. The role includes partnering with Client GRA CMC (regulatory scientists) to develop complex regulatory strategies and with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.
