The Director, Global Regulatory Leader will:
• Create coherent and unified global regulatory strategies.
• Facilitate and coordinate team meetings, represent Global Regulatory Affairs and provide regulatory expertise on the Compound Development Team (CDT) and Clinical Team (CT) to facilitate successful product development globally.
• Develops and updates contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile.
• Leads the preparation of regulatory dossiers for submission to Health Authorities.
• Leads Global Regulatory Team(s) to develop global marketing approval submission plans and timing, modifies submission plans and aligns with sourcing, Intellectual Property and launch strategies as appropriate.
• Establishes Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to Health Authorities.
• 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.
• May manage a staff, including staff that supports additional portfolio products.
• Provide input to and be accountable for the preparation of dossiers for submission to HA (NDA / MAA / IRD/IND/CTA).
• Work with the clinical team to develop clinical trial submission plans.
• Work with the GRT to develop global marketing approval submission plan and timing.
• Conduct licensing evaluations (as needed).
• Co-lead the Labeling Working Group in making strategic decisions, including creation of labeling strategy.
• 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 in a scientific discipline is required.
• An advanced degree (MS, PhD, MD or Pharm D) is preferred.
• A minimum of 10 years of pharmaceutical industry or health authority experience, and at least 6 years of Regulatory Affairs, or related experience is required.
• Experience with large molecule biologics is preferred.
• Experience within a supervisory capacity or managing teams within matrix environment is required.
• Wide range of experience in Regulatory Affairs and 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 biology and chemistry relevant to the Cardiovascular and Metabolism therapeutic area is preferred.
• Experience developing regulatory strategies and an understanding of product development is required.
• This position will be located in Raritan, NJ or Spring House, PA, and will require 10-20% travel, both International and Domestic.
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