Director, Regulatory Affairs

ThinkingAhead

Join a smaller but rapidly growing biotechnology company in the highly desired Boston area as Director of Regulatory Affairs!

This is a hands on, hit the ground running, your voice matters type of position! You will gain valuable experience through the entire life cycle of the unique and incredibly needed products this company is working on. Join a team that's passionate about what they're working on and who they're working with!

*A few company perks: monthly insurance premiums are completely covered, flexible work at home options, free lunch provided daily, and unlimited vacation time!

Responsibilities include: 
  • Ensure development of robust, global regulatory strategies for assigned projects and be accountable for adapting and/or maintaining the regulatory strategy as needed.
  • Provide ongoing regulatory guidance to project teams.
  • Interact directly with FDA and other health authorities and ensure that interactions with regulators are properly communicated to the development team.
  • Develop submission plans and timelines in accordance with project goals.  Lead cross-functional efforts to deliver high quality submissions, e.g., INDs, CTA, orphan applications.  Ensuring that Manager is aware of any major issues with the project, including any changes to plan or risks.
  • Manage submission development.  Develop and/or author content as applicable.  Direct subject matter experts in content development and authoring. 
  • Triage and coordinate responses to questions from regulatory authorities.
  • Contribute to initiatives to improve processes within the Regulatory department.
  • Keep abreast of regulatory guidance and technical/scientific developments relevant to projects. Contribute to commenting on draft regulations and assess future areas for influencing the regulatory environment.
Qualifications:
  • 8-10 years relevant Regulatory Affairs experience 
  • Well-versed in regulatory strategy, and regulatory writing
  • Experience as primary regulatory author for IND and CTA documents
  • Knowledgeable in ICH, FDA and EMA guidelines
  • Ability to work independently and thrive in a fast-paced environment
  • Excellent communication skills