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Associate Director Regulatory Affairs

3 months ago

United Kingdom Life Science People Full time

Associate Director Regulatory Affairs

Remote

Competitive salary + bonus + car allowance + shares/stocks


Reporting to the Vice President of Regulatory Affairs, the Associate 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.


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.


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

  • Works with the Lead, Regulatory Affairs, and the 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 internal program focused development teams, and on subsidiary organization project teams, study management teams, clinical teams, and other sub-teams
  • 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
  • Responsible, with direction from Lead, Regulatory Affairs, for development and acquisition of required supplementary regulatory skills and knowledge
  • 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 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