Director/Manager Regulatory Affairs (f/m/d)
at atai (View all jobs)
Location: San Diego or remote on the west or east coast
- A fast-paced environment where you’ll work on a wide range of topics
- Be a major contributor to the success of a well-positioned, well-financed, rapidly growing biotech company
- Become part of creating a radically new and impactful paradigm shift in drug development and patient care
- An open, results-driven, and meritocratic start-up culture
- To work from where you want when you want, and with the device and equipment you choose
- The opportunity to participate in the company’s success via a share option plan
- Work with the Lead of 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.
- Serve as Regulatory representative on selected atai development teams, on subsidiary organization project teams, study management teams and clinical teams
- Responsible for overseeing and supporting 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/or 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 regulatory authorities
- Initiate and contribute to atai process improvements.
- Contribute to the production of project-related documents, budgets, presentations, patents and regulatory submissions as required.
- You graduated from a top-tier university with an excellent academic track record
- +10 years of experience in the pharmaceutical industry
- +5 years of hands-on regulatory experience
- Thorough understanding of relevant FDA, EMA, and ICH regulations and guidances.
- Knowledge of Canadian, Australian and New Zealand clinical trial regulations and procedures is a plus.
- Work is performed under moderate/minimal supervision of the Lead, Regulatory Affairs.
- Excellent teamwork, collaboration and interpersonal skills
- Excellent organization skills and ability to work on a number of 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.
- Outstanding written and verbal communication and presentation skills
- Attracted to a life sciences biotechnology environment with potential for future continued grow
How to apply
Join us to improve the lives of millions suffering from a real unmet medical need – Apply today via the “Apply for this Job” – button on the top right.
If you have any questions, don’t hesitate to contact us at firstname.lastname@example.org.