Regulatory Affairs Director
Calliditas Therapeutics AB / Biomedicinjobb / Stockholm
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Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product, TarpeyoTM, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. As of December 15th 2021, the FDA has approved the commercialization of Nefecon (TARPEYOTM) in the United States thus making it the first and only FDA-approved treatment. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit
www.calliditas.com (
http://www.calliditas.com) for further information.
Position summary
As a Regulatory Affairs Director you will be reporting to the Vice President of Regulatory Affairs and be a part of a team of four. You will contribute to develop and implement global regulatory strategies and will play a hands-on role in regulatory submissions leading to first cycle approvals.
Key tasks and responsibilities
• Lead and contribute to regulatory strategies in assigned projects that expedite development, maximize the probability of success, and mitigate risks.
• Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as CTAs/INDs, amendments, annual updates, briefing documents, paediatric investigation plans, health authority information requests and NDAs/MAAs.
• Managing and leading the planning and preparation of meeting requests and meeting packages for health authority interactions.
• Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards.
• Provide regulatory guidance to project teams and lead the development, strategy and execution of regulatory submission documents while working collaboratively cross-functionally with the team and a variety of personnel and staff.
Education and experience requirements
• Education in the natural sciences space with an MSc degree in Pharmacy, Chemistry or similar
• Ideally 8+ years' experience in industry and 5+ years in Regulatory Affairs.
• Experience in preparing regulatory strategies/regulatory development plans, highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments.
• Experience with clinical trial submissions and approvals.
• Previous experience in a senior regulatory role, including health authority interactions is required, and experience with NDA/MAA dossier compilation and submissions is desirable.
• In-depth understanding of regulations and guidelines governing all phases of drug development.
We believe that you have a strategic mindset, innovative yet pragmatic/solution-oriented thinking and at the same time keen to also work in an operational role with attention to detail.
Reasons to join the Calliditas Team
• Be a part of a global leader in IgA- Nephropathy and a rapidly growing commercial-stage pharmaceutical company.
• Be a part of a very exciting stage where TARPEYOTM has been approved by the US FDA.
• Be a part of the commercialization of TARPEYOTM and our focus to file for approval with EMA.
• Get in on bonus and benefit programs.
• Work in fast-paced small company environment.
Welcome to join the Calliditas Team!
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2022-04-06ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2022-09-23
Klicka på denna länk för att göra din ansökanFöretagCalliditas Therapeutics AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Calliditas Therapeutics AB (org.nr 556659-9766)
Arbetsplats Calliditas Therapeutics
Jobbnummer 6513843
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