Associate Director Director Regulatory Affairs
We are looking for an Associate Director or a Director, Regulatory Affairs who will be responsible for day-to-day regulatory activities of early/late phase investigational products, leads the writing and submission of IND/CTA/amendments and future marketing application submissions, provides guidance to the team on regulatory filings and responses, and provides critical regulatory intelligence and guidance back to the team. This role participates in a cross-functional team, partners with key internal/external team members/stakeholders, and partners with Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. This position will report to the Senior Director, Head of Global Regulatory Affairs.
What You Will Do Provide input and regulatory support to cross-functional development teams responsible for the translation, development and registration of Cogent's products Develop and execute regulat Apply now and work remotely at Cogent Biosciences
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