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 candidate, Nefecon, 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. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
Reporting to the Vice President of Regulatory Affairs, the successful candidate will contribute to developing and implementing 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 10+ years’ experience in industry and 7+ 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
- Strategic mindset, innovative yet pragmatic/solution-oriented thinking, 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 clinical-stage pharmaceutical company
- Be a part of our NDA and MAA submission and approval phase
- Get in on bonus and benefit programs
- Fast paced small company environment
Welcome to join the Calliditas Team!