Associate Director, Regulatory Liaison - Oncology

Associate Director, Regulatory Affairs

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 :

Required Experience and Skills :

Preferred Experience and Skills :

Required Skills : Accountability, Adaptability, Biological Sciences, Cross-Functional Teamwork, Drug Development, Global Strategy, Innovation, Regulatory Affairs Management, Regulatory Strategy Development, Regulatory Submissions, Scientific Research, Strategic Thinking

Preferred Skills : BLA Submissions, Clinical Research, IND Submission, NDA Submissions, Oncology