Associate Director, Regulatory Affairs

Job Description The Role: The Associate Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the product pipeline. The Associate Director, Regulatory Affairs provides regulatory support for oncology products in early-stage and late-stage development through post approval. This role will also serve as the regulatory lead for assigned projects and be responsible for applying regulatory expertise and experience to product development programs. Additionally, the Associate Director is responsible for the oversight of clinical trial investigational new drug applications (INDs), clinical trial applications (CTAs) and marketing applications - i.e. biologics license applications (BLAs) and new drug applications (NDAs). For more complex applications, this role will lead the finalization of regulatory submission documents and regulatory submissions for completeness and quality in global accordance with regulatory agency requirements, standards, and corporate practices. This position will report to the Director of Regulatory Affairs. What You'll Do: Working as a regulatory lead to develop regulatory strategies for oncology development programs (which may range from FIH through post-marketing stage) Address complex issues by providing solid regulatory solutions and guidance to the cross-functional teams and senior management Monitor global regulatory changes that may impact asset development Provide tactical support and operational expertise with "hands on" support as needed Ensure compliance of regulatory strategies and submissions Assess project plans and timelines; manage staff effectively and collaboratively to ensure all projects are appropriately prioritized and key goals are met on time Contribute to the continuous improvement of existing department processes and create new processes to support the evolution of the company Qualifications: B.S/M.S. and 8+ years of work experience in pharmaceutical regulatory affairs 5+ years of regulatory experience working with global development and submission plans Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU Must have experience filing INDs and/or NDAs and engagement with FDA and other regulatory bodies Preferred Qualifications: Capable of strategic thinking and proposing innovative solutions to regulatory problems Demonstrates excellent verbal and written communication skills Experience managing a regulatory team Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. Apply Now:Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!#J-18808-Ljbffr

Created: 2025-03-09