Associate Director, Regulatory Affairs – 22-126
Fully Remote
Description

 Will assist in the development of regulatory strategies to advance clinical programs, will interact with clinical teams providing regulatory guidance to ensure successful execution of clinical studies and regulatory submissions. Must build and maintain effective communication and constructive working relationships with external collaborators and regulatory authorities will be. This is a remote-based position. 


 Responsibilities:

  • Management of regulatory aspects of clinical development program
  • Accountable for all relevant Health Authority submissions and approvals for assigned clinical study programs
  • Assist with implementation of regulatory strategies
  • Provide regulatory guidance to clinical teams
  • Supervise the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs
  • Assist with mentoring junior regulatory team members
  • Understand and be able apply comprehensive understandings of clinical regulations and guidelines (FDA, ICH) for improvements of regulatory success and compliance
Requirements
  •  Bachelor’s degree required with minimum of 8 years in pharma industry, and drug development experience in Regulatory Affairs
  • Advanced degree in Biological Science and 5 years pharma industry in Regulatory Affairs
  • Solid understanding of drug development process and regulatory requirements required
  • Ability to understand and help interpret sophisticated scientific issues as it relates to regulatory requirements and strategy.
  • Experience in oncology/rare-diseases drug development a plus
  • Advanced scientific related degree a plus
  • Experience filing INDs, CTAs, and/or NDA/BLAs to FDA and outside US regulatory agencies a plus
  • Knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus
  • Able to work well with others and communicate with senior leadership
  • Strong oral and written communication skills, and negotiation skills
  • Willing to set and drive aggressive project timelines
  • Capable of strategic thinking and proposing solutions to regulatory problems
  • Must be proficient in Microsoft Word, Project, PowerPoint, and Adobe Acrobat
  • A team player, who listens effectively and invites response and discussion
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner