The Director, Global Regulatory Leader - Oncology will:
• Create coherent and unified global regulatory strategies through the facilitation and coordination of team meetings, representation of Global Regulatory Affairs and provision of regulatory expertise on the Compound Development Team (CDT) and Clinical Team (CT).
• Ensures regulatory strategies throughout lifecycle of compounds as appropriate. Refines regulatory strategies as needed and ensures strategy is in alignment with Therapeutic Area portfolio and regional strategies.
• Leads the preparation of regulatory dossiers for submission to Health Authorities (NDA / MAA / IRD/IND/CTA). Develop strategy for providing responses to HA questions (ensure alignment with global strategy).
Watch: Career Advice
• Works with the Global Regulatory Team to provide input for target labeling, and the Labeling Working Group in making strategic decisions, including the creation of Labeling strategy. Negotiate regional labeling with HAs (ensure alignment with global strategy) as appropriate.
• Provide input to commercial Drug Product formulation, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy.
Qualifications
• A minimum of Bachelor’s degree is required, preferably in a scientific or technical related disciple. An advanced degree (MS, PhD, MD or Pharm D) is preferred.
• A minimum of 10 years of experience in a highly regulated environment, such as pharmaceutical, medical device, or consumer industry, with at least 6 years of Regulatory Affairs, Compliance and/or Quality experience is required.
• A minimum 4 years of experience within a supervisory capacity or managing teams within matrix environment is required.
• Experience leading interactions with Health Authorities is required.
• Working knowledge of worldwide Health Authority laws, regulations, guidance and global regulation submission routes available for new study drugs is required.
• Knowledge of labeling aspects is required.
• Solid understanding of the Oncology therapeutic area is required.
• Experience developing regulatory strategies and an understanding of product development is required.
• This position will be located in Raritan, NJ, Titusville, NJ, Spring House, PA, or High Wycombe, UK, and will require up to 10-20% domestic and international travel.
Send To A Friend
Subscribe to us
100% Free.
close