The role

As a Director of Regulatory Affairs you will be reporting to the Vice President Regulatory Affairs and be a part of a team of five. 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.

Your key tasks will include:

• 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.

Previous experience

• 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 within specialty products with strong growth ambitions and a strong pipeline
• Fast paced small company environment
• A unique corporate culture
• Dedicated, experienced and highly skilled colleagues
• Participate on bonus and benefit programs

About Calliditas

Calliditas is a commercial stage biopharmaceutical company 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, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO® and conditional marketing authorization by the European Commission under the trade name KINPEYGO®.

TARPEYO and KINPEYGO® are the first and only treatments approved for IgA nephropathy by the FDA and EMA, respectively.

Calliditas also has a pipeline in orphan-focused indications. Calliditas is conducting a Phase 2b/3 clinical trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in head and neck cancer with its NOX inhibitor product candidate, setanaxib.

Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).

All applications are handled by Bossanova People Agency.

Calliditas has an exclusive partnership with Bossanova People Agency regarding this recruitment. We kindly request that other external recruitment companies refrain from contacting us & Calliditas about this job posting.