Associate Director, Regulatory Liaison - Oncology

Job Overview 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. 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. Track, author, shepherd, and review responses to Agency requests, including leading these tasks as needed. Implement strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications. Communicate with Agencies and attend Agency meetings as needed to assist the global regulatory lead. Participate as an active member on the global regulatory team and attend cross‑functional meetings. Conduct research and review of guidelines, regulatory precedence, and competitive intelligence to facilitate development of regulatory strategy. Assist the global regulatory lead in authoring regulatory strategy documents. Collaborate and communicate regulatory strategy to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC), and 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 the global regulatory lead in label development. Assist with process improvement initiatives. Perform regulatory administrative activities as needed. Education and Minimum Requirements M.D. or Ph.D. or other related doctoral degree in a biological science, chemistry, or related discipline. Master’s Degree with at least 2 years of relevant experience in the pharmaceutical industry. Bachelor’s Degree, with at least 5 years of relevant experience in the pharmaceutical industry. 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. Strong scientific and analytical skills with attention to detail. Preferred Experience and Skills Experience with oncology products. Equal Employment Opportunity We are an Equal Employment Opportunity Employer and 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. Salary Range: $142,400.00 – $224,100.00 #J-18808-Ljbffr