Senior Director, Regulatory Affairs

Remote

Working as part of a passionate, collaborative team, the Senior Director of Regulatory Affairs is responsible for providing regulatory leadership and oversight in delivering high quality and efficient regulatory submissions and approvals for selected global small molecule pharmaceutical development programs within atai and its subsidiary organizations. You will have the opportunity to lead our regulatory strategy and drive submissions for innovative biotech products.. In addition, this position may be responsible for select regulatory due diligence in the context of business development activities.


Regulatory Affairs serves as the interface between regulatory authorities and atai project teams, anticipating what the regulatory authority will require before approving the product. 


Who we are: 


atai Life Sciences is a biopharmaceutical company focused on developing novel treatments for mental health disorders so that everyone, everywhere, can live a more fulfilled life. To achieve this, we are developing psychedelic and non-psychedelic compounds and cutting-edge digital therapeutic tools, and we are excited about anything that might mean a true leap forward for our patients. We operate a hybrid virtual/in-person working model, with most of the team spending time in the office as required. atai hubs are located in Berlin, New York City, and San Diego. 


What you will achieve in your first 6 months:


  • Accelerated your learning about atai people, processes, and portfolio, are clear on the regulatory activities that you are leading, and have developed a good understanding of the strategic partnerships internally and externally that drive value for atai 
  • Demonstrated effective planning and execution of cross-functional strategies that enable pre-IND/IND meeting requests, associated submissions, and meetings (where applicable) 
  • Have built trust and credibility as a regulatory subject matter expert 


The specifics of your day-to-day will include:


  • Works with the atai Development Team, and with select project teams within subsidiary organizations to develop and oversee program-specific regulatory, clinical, and development strategies. 
  • Serves as Regulatory representative on selected atai internal program focused development teams, and on subsidiary organization project teams, study management teams, clinical teams, and other sub-teams. 
  • Participates in atai development team meetings and present project status updates and strategic approaches to moderately complex programs/projects. 
  • Responsible for overseeing and supporting, as needed, regulatory submission preparation activities for selected development programs in line with ICH requirements, regional requirements and scientific and company standards and procedures. Focus will be on IND/CTA filings and associated interactions, and may include safety reports, protocols, information amendments, responses to requests for information, IND Annual Reports/DSURs, and new investigator amendments. 
  • Manages the writing and review of key documents for INDs, IMPDs and CTAs and other regulatory submissions, as required. 
  • Represents the company as the Regulatory Affairs expert before U.S. and other global regulatory authorities in support of atai and subsidiary company programs. 
  • Responsible for development and acquisition of required supplementary regulatory skills and knowledge. 
  • May initiate or contribute to atai process improvements, which have a significant impact on the working of the Regulatory Affairs function, applicable regulations and internal quality systems. 
  • Works collaboratively within a multi-disciplinary environment, both within atai and subsidiary organization and with external consultants and CDMO/CRO teams. 
  • Contributes to the preparation of project-related documents, budgets, presentations, patents and regulatory submissions as required.  
  • Interpret and anticipate impact of new guidelines and initiate change in response to changing environment. 


Qualifications / experience that we would like to see:

 

  • 10+ years of experience in the pharmaceutical or biotech industry 
  • 5+ years of hands-on product development regulatory experience 
  • Thorough understanding of relevant FDA, EMA, ICH guidelines (Aus/NZ a plus) and related regulations, including ISO, QSR. Knowledge of device regulations is a plus US 510(k) and DeNovo, EU MDR. 
  • Knowledge of major market regulations and procedures (US essential) 
  • Excellent organization skills and ability to work on multiple projects with tight timelines 
  • Candidates must possess a strategic and solution-oriented mindset 
  • Is a creative, analytical problem solver, who acts decisively, yet communicates the risks and benefits associated with all potential solutions so that informed business decisions can be made 


Who will be successful in this role:


Those who succeed at atai will be strongly aligned with our values:


❤️ Conscious Care: We take every action in service of our ultimate goal: to heal mental health disorders for all while caring for ourselves and our team. 

🦸 Bold Entrepreneurship: We are “loosely coupled but tightly aligned” as we strive for excellence over perfection, fast and focused to accelerate innovation for patients. 

🧑‍🤝‍🧑 Collaborative Innovation: individuals and teams work together with good humor and no drama, valuing different perspectives and diversity of thought, background, nationality, and style.

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