Assoc. Director / Director Of Regulatory Affairs

This role is on a team of passionate, collaborative people, led by the Vice President of Regulatory Affairs, the AssociateDirector / Director of Regulatory Affairs is responsible for providing regulatory oversight and support for both the operational and supervised strategic regulatory activities for, selected global small molecule pharmaceutical development programs within atai and its subsidiary organizations. Focus for oversight includes ensuring appropriate manufacturing and control of drug substances and drug products, preclinical development activities, and clinical trial strategies supporting regulatory filings for the conduct of planned clinical studies. 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, effectively 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 Lead, Regulatory Affairs, and the atai Development Team, and with moderate/minimal supervision, 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
• Participate 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
• Manage the writing and review of key documents for INDs, IMPDs and CTAs and other regulatory submissions, as required
• Represent the company as the Regulatory Affairs expert before U.S. and other global regulatory authorities in support of atai and subsidiary company programs
• Responsible, with direction from Lead, Regulatory Affairs, 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 or other departments
• Work collaboratively within a multi-disciplinary environment, both within atai and subsidiary organization and with external consultants and CDMO/CRO teams
• Contribute to the preparation of project-related documents, budgets, presentations, patents and regulatory submissions as required

Qualifications / experience that we would like to see:

• +10 years of experience in the pharmaceutical, biotech, or medical device 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)
• Combination product and Digital Therapeutics is a plus
• Excellent organization skills and ability to work on multiple projects with tight timelines
• 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.
• ✋ Radical Responsibility: We take full responsibility for our circumstances. We grow and learn from failures, always looking to improve.