Associate Director, Regulatory Liaison - Oncology

Role Summary

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

• 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

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline
• Master‚Äôs Degree with at least 2 years of relevant experience in pharmaceutical industry
• Bachelor‚Äôs 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 required
• Strong scientific and analytical skills with attention to detail

Preferred Experience And Skills

• Experience with oncology products is highly preferred

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