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.

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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 regulatory strategy in support of overall program goals and objectives
• Provide day-to-day management of all regulatory aspects of ongoing and planned clinical development programs
• Lead the coordination, preparation and timely submission of regulatory documents and responses to queries from authorities (e.g., INDs, NIH/RAC submissions, BLAs, MAAs)
• Contribute to the development of regulatory content to support regulatory agency submissions
• Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
• Establish relevant processes and procedures to support the Regulatory Affairs function activities
• Initiate and prepare regulatory agency correspondences to facilitate expedient and efficient product development and registration of assigned products
• Stay up-to-date on changes in regulatory guidelines and best practices that may impact Cogent’s product candidates
• Create plans to meet regulatory requirements, anticipate regulatory changes, build relationships with regulatory agencies, oversee regulatory submissions, and ensure compliance for Cogent's product candidates pre and post-approval

What You Will Bring

• Bachelor’s, Master’s or PhD in a scientific or medical discipline with a minimum of 6 years in Regulatory Affairs in a pharmaceutical, biotechnology, contract research organization (CRO) or related industry is required.
• Experience with leading major submissions and health authority meetings
• Demonstrated, hands-on experience, managing and preparing regulatory submissions especially Clinical Trial Applications outside of North America with a primary focus on European applications through the Clinical Trials Information System (CTIS).
• Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.

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