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Sr. Director, Regulatory Affairs

1 month ago

Boston, United States The Steely Group Full time
The Sr. Director, Regulatory Affairs serves as a Health Authority liaison and Regulatory Project Leader for multiple projects in various stages of development. The Sr. Director serves as a strategic regulatory leader for assigned drug development programs and uses extensive knowledge to advise project teams on regulatory requirements to drive successful global development strategies. She/He manages the planning, preparation, and submission of complex regulatory dossiers in support of project goals; leads cross-functional teams to deliver high-quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc.; and provides strategic direction and mentoring to staff, foster staff engagement and development.

Responsibilities:
  • Manages the planning, preparation, and submission of complex regulatory dossiers in support of project goals.
  • Leads preparation of high-quality meeting packages, drives meeting strategy and team preparation. 
  • Contributes to the generation of policies and to the globalization of work processes.
  • Maintains knowledge of US, EU and ICH regulatory requirements and guidelines and anticipates, assesses, and communicates changes in regulatory framework throughout the organization, as relevant.
  • Keeps abreast of changing regulations and health authority actions, and applies knowledge to develop regulatory strategy for assigned projects in the region.
  • Serves as a strategic regulatory leader for assigned drug development programs and uses extensive knowledge to advise project teams on regulatory requirements to drive successful global development strategies. 
  • Leads cross-functional teams to deliver high quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc.
  • Provides strategic direction and mentoring to staff, foster staff engagement and development.
  • Serves as the primary liaison with Health Authorities for assigned products.  
  • Negotiates with Health Authorities, aid in the interpretation of Health Authority feedback.
  • Builds relationships with internal and external stakeholders and integrates regulatory and drug development knowledge to facilitate ways of working and achievement of project and company goals.

Requirements:
  • Bachelor’s degree in life sciences, Advanced degree preferred.
  • 10+ years of relevant regulatory experience
  • Oncology regulatory project leadership experience 
  • Experience managing staff
  • Experience developing  regulatory strategies for products intended to treat chronic diseases and products intended to treat severe, life-threatening diseases.  
  • Experience with document management systems, RIMS
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
  • Strategic thinker, able to interpret complex regulations and apply them appropriately, throughout the product development lifecycle, 
  • Ability to quickly integrate information, define and mitigate risk, and prioritize activities among multiple projects.