Job Description

Job Description:

• Support line manager with the day-to-day management of regulatory aspects of at least one clinical development program 
• Responsible for relevant submissions for assigned program(s). 
• Represent the Global Regulatory Sciences function on cross functional teams 
• Support line manager in developing and implementing long?and short-term product regulatory strategies/plans 
• Plan for and lead preparation efforts for health authority meetings  
• Provide guidance to external vendors and consultants as needed 
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs 

• Bachelor’s degree in scientific discipline; advanced scientific related degree a plus 
• 4 years or more in drug development; direct Regulatory experience is a plus  
• Experience in oncology/rare diseases drug development a plus 
• Ideally experienced in filing and managing INDs to FDA 
• Working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus 
  
• Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships 
• Well organized, with an attention to details and capable of managing multiple deliverables 
• A collaborator who communicates in an open, clear, complete, timely and consistent manner 
• At home in a results-driven, highly accountable environment where you can make a clear impact 
• A team player, who listens effectively and invites response and discussion 
• Flexible and adaptable in ambiguous situations 
• Must be proficient in Microsoft WORD, Excel, PowerPoint as well as SmartSheet and Adobe Acrobat 

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