Associate Director, Regulatory Affairs

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 DoWorking 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 QualificationsB.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 QualificationsCapable of strategic thinking and proposing innovative solutions to regulatory problems Demonstrates excellent verbal and written communication skills Experience managing a regulatory team Additional InformationDeciphera offers a comprehensive benefits package that includes but is not limited to the following: Non-accrual paid time off Summer vacation bonus Global, company-wide summer and winter shutdowns An annual lifestyle allowance Monthly cell phone stipend Internal rewards and recognition program Medical, Dental, and Vision Insurance 401(k) retirement plan with company match Life and Supplemental life insurance for family Short and Long Term Disability insurance Health savings account with company contribution Flexible spending account for either health care and/or dependent care. Family planning benefit Generous parental leave Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland. EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis. Seniority levelDirector Employment typeFull-time Job functionScience IndustriesPharmaceutical Manufacturing#J-18808-Ljbffr

Created: 2025-03-09