Associate Director – Global Regulatory Strategy – Oncology

Associate Director – Global Regulatory Strategy – Oncology

Requirements

• BA/BS degree in a scientific/engineering/healthcare discipline required
• Masters, PharmD or PhD preferred
• 7+ years of experience in the Pharmaceutical industry preferred
• 5+ years of experience in Regulatory strategy or relevant training/experience preferred
• Experience in oncology therapeutics highly preferred
• Strong knowledge of current US regulations and knowledge of ex-US regulations
• Strong experience with CTD format and content of regulatory filings
• Exceptional written and oral communication
• Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance at least in the US
• Demonstrate strong organizational skills, including the ability to prioritize workload
• Experience in developing regulatory strategies at various drug development time points
• Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
• Experience in authoring regulatory documents
• Knowledge and understanding of applicable regulations
• Experience working on products across all stages of product development.

Responsibilities

• Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading the Global Regulatory Sub-teams with support from the GRL
• Sets strategic direction for the US market, in collaboration and alignment with the global product strategy with GRL, Global Regulatory Sub-Teams and project teams for assigned programs
• Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions
• Leads the strategy for US FDA interactions with the cross functional team, including development of content, format and accountability for regulatory submissions and related supplements and amendments, FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, etc.
• Conducts risk assessment and identifies potential areas of regulatory concern for assigned projects or programs and responds to emerging health authority regulations and requirements
• In collaboration with the cross functional team, leads the response to health authority requests for additional data, organizes and manages participation in meetings relevant to aspects of compound development
• Reviews and may approve regulatory documents prior to submission to respective regulatory authority(ies)
• Serves as primary point of contact and negotiates directly and effectively with FDA and other health agencies for assigned programs
• May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant
• Identify areas in need of improvement and lead the development and implementation of process improvements.

Preferred Qualifications

• 7+ years of experience in the Pharmaceutical industry preferred
• 5+ years of experience in Regulatory strategy or relevant training/experience preferred
• Experience in oncology therapeutics highly preferred