Right here is the job advert
Work as a part of a passionate staff, collaboration, theSenior Director of Regulatory Affairsis liable for offering regulatory management and oversight within the supply of top quality and efficient regulatory submissions and approvals for chosen international small molecule pharmaceutical improvement applications at atai and its subsidiary organizations. You’ll have the chance to drive our regulatory technique and lead displays for revolutionary biotech merchandise.. Moreover, this place could also be liable for choosing regulatory due diligence within the context of enterprise improvement actions.
Regulatory Affairs serves because the interface between regulatory authorities and atai challenge groups, anticipating what the regulatory authority would require earlier than approving the product.
Who we’re:
Atai Life Sciences is a biopharmaceutical firm centered on growing new remedies for psychological well being problems so that everybody, all over the place, can dwell a fuller life. To attain this, we develop psychedelic and non-psychedelic compounds and cutting-edge digital therapeutic instruments, and we’re enthusiastic about something that would imply an actual leap ahead for our sufferers. We function a hybrid digital/in-person work mannequin, with many of the staff spending time within the workplace as wanted. Atai facilities are situated in Berlin, New York Metropolis and San Diego.
What you’re going to get in your first 6 months:
- Speed up your studying concerning the individuals, processes and portfolio of atai, be clear concerning the regulatory actions you lead, and develop a very good understanding of the strategic companions internally and externally that drive worth for atai .
- Demonstrated efficient planning and execution of cross-functional methods enabling pre-IND/IND assembly requests, related displays and conferences (the place relevant)
- Have constructed belief and credibility as an knowledgeable in regulatory issues
Your day-to-day specifics embrace:
- Works with the Atai Improvement Staff, and with chosen challenge groups in subsidiary organizations to develop and oversee program-specific regulatory, scientific and improvement methods.
- Serves as regulatory consultant on atai inner program centered improvement groups, and on subsidiary group challenge groups, research administration groups, scientific groups and different sub-teams.
- Take part in atai improvement staff conferences and current challenge standing updates and strategic strategy to reasonably complicated applications/initiatives.
- Accountable for overseeing and supporting, as wanted, regulatory submission preparation actions for chosen improvement applications in keeping with ICH necessities, regional necessities, and scientific and enterprise requirements and procedures. The main target can be on IND/CTA recordsdata and related interactions, and should embrace security studies, protocols, data amendments, responses to data requests, IND/DSUR Annual Experiences, and new amendments to the investigator.
- Handle the writing and evaluation of key paperwork for IND, IMPD and CTA and different regulatory submissions, as required.
- Represents the corporate because the Regulatory Affairs knowledgeable earlier than the USA and different international regulatory authorities in assist of the applications of the Atai and the subsidiary firm.
- Accountable for the event and acquisition of required extra regulatory expertise and data.
- Might provoke or contribute to atai course of enhancements, which have a big impression on the work of the Regulatory Affairs operate, relevant laws and inner high quality programs.
- Works collaboratively in a multidisciplinary setting, each inside the atai and subsidiary organizations and with exterior consultants and CDMO/CRO groups.
- Contribute to the preparation of project-related paperwork, budgets, displays, patents and regulatory submissions, as required.
- Interpret and anticipate the impression of recent tips and provoke change in response to the altering setting.
{Qualifications}/expertise we wish to see:
- 10+ years of expertise within the pharmaceutical or biotech business
- 5+ years of regulatory product improvement expertise
- Thorough data of related FDA, EMA, ICH (Aus/NZ a plus) tips and associated laws together with ISO, QSR. Data of system laws is a plus US 510(okay) and DeNovo, EU MDR.
- Data of the principle market guidelines and procedures (US important)
- Wonderful organizational expertise and skill to work on a number of initiatives with tight deadlines
- Candidates should possess a strategic and solution-oriented mindset
- He’s a inventive and analytical drawback solver, who acts decisively, however communicates the dangers and advantages related to all potential options in order that knowledgeable enterprise selections might be made.
Who will succeed on this position:
Those that succeed at atai can be strongly aligned with our values:
❤️ Aware Care:We take each motion within the service of our final objective: curing psychological well being problems for everybody whereas caring for ourselves and our staff.
Daring Entrepreneurship:We’re “loosely coupled however intently aligned” as we try for excellence over perfection, quick and centered to speed up innovation for sufferers.
Collaborative Innovation:people and groups work along with good humor and with out drama, valuing totally different views and variety of thought, background, nationality and magnificence.
