Senior Director, Regulatory Affairs

  • Location:Cambridge, MA
  • Department:Regulatory Affairs
  • Type:Full Time
  • Min. Experience:Executive

RESPONSIBILITIES:

  • Provides leadership and management to the RA functions
  • Oversees the establishment and maintenance of the RA programs, policies, and procedures
  • Provides oversight and guidance to ensure compliance with all applicable regulations and guidelines
  • Directs all regulatory activities to support development and commercialization of products and product candidates  
  • Represents the company to regulatory authorities
  • Supports clinical studies including, clinical study design, data analysis, and data reporting
  • Ensures appropriate regulatory representation and strategic regulatory input to cross-functional product development teams
  • Responsible for keeping Executive Leadership Team informed of regulatory status of products and regulatory issues
  • Ensures regulatory support of pharmaceutical development, manufacturing operations, conduct of clinical and nonclinical studies, and marketing and sales activities
  • Oversees regulatory filings to ensure accuracy, quality and compliance
  • Collaborates with cross-functional partners to ensure successful global development, registration planning and implementation
  • Leads and develops RA staff to ensure ongoing professional development
  • Communicates regulatory policies and provides clarity on regulatory expectations
  • Responsible for regulatory review and approval of documents, as required
  • Analyzes the global regulatory requirements and environment, and provides assessments of the impact of new and changing regulations
  • Other duties as assigned

EDUCATION AND EXPERIENCE: 

  • Bachelor’s degree in life sciences or a related field required.  Advanced degree preferred
  • At least 10 years’ experience in the pharmaceutical/biotechnology industry within Regulatory Affairs function with meaningful oncology experience
  • Experience with regulatory submissions including IND’s, CTAs, and marketing applications
  • Strong knowledge of applicable regulatory requirements including but not limited to GXPs
  • Previous experience interacting with FDA, EMA and other regulatory agencies
  • Very strong written, verbal, and interpersonal communication skills
  • Ability to work independently and in close collaboration in a cross-functional team setting