Associate Director Regulatory Liaison - Oncology

Job Description The Associate Director, Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team. The individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence. The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Primary Responsibilities: Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests. Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications. Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead. Participating as an active member on the global regulatory team. Individual will attend cross-functional meetings as required, in collaboration with, and to assist the global regulatory lead. Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the global regulatory lead in authoring of regulatory strategy documents. Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., clinical research, non-clinical safety assessment). Support maintenance (e.g., quality compliance and life cycle management) of oncology programs. Support of global regulatory lead in label development. Assisting with process improvement initiative. Performing regulatory administrative activities, as needed. Education Minimum Requirements: Bachelor’s Degree, with at least 5 years of relevant experience in the pharmaceutical industry. Master’s Degree with at least 2 years of relevant experience in pharmaceutical industry. M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline with relevant experience. Required Experience and Skills: Experience in drug development Prior regulatory experience interacting with a major regulatory agency Excellent communication skills (both oral and written). Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects. Flexibility required. Strong scientific and analytical skills with attention to detail. Preferred Experience and Skills: Experience with oncology products is highly preferred #EligibleforERP Required Skills: Cross-Functional Teamwork, Global Regulatory, Investigational New Drug, Label Development, Life Cycle Planning, Pharmaceutical Industry, Product Registrations, Regulatory Communications, Regulatory Documents, Regulatory Experience, Regulatory Filings, Regulatory Reporting, Regulatory Strategies, Regulatory Submissions, Stakeholder Engagement Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. 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