About Us

Calliditas Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of novel treatments in areas of high unmet medical need, with an initial focus on renal and hepatic diseases. As part of the Asahi Kasei group, we are working toward building a unified global organization with a strong pipeline and a shared commitment to scientific excellence and patient impact.

Recently acquired by Asahi Kasei, Calliditas is now integrated with Veloxis Pharmaceuticals, a company based in North Carolina, USA, which is also part of the Asahi Kasei group. Together, we are establishing a global presence with teams spanning Europe, the U.S., and Japan. This collaboration allows us to leverage our collective expertise and expand our impact in the global healthcare landscape.

As part of this continued growth and integration with Veloxis and Asahi Kasei Pharma, we are now hiring a Director, Global Regulatory CMC to be based in Stockholm. This position offers the opportunity to work within a global team and collaborate closely with our partners in Japan and the U.S., supporting our ongoing commitment to developing and delivering life-changing treatments to patients worldwide.

Position Summary

The Director, Global Regulatory CMC will lead and execute CMC regulatory strategies throughout the product lifecycle, including development, registration, and post-approval activities. This role will provide strategic input and hands-on support for regulatory submissions globally, with a focus on coordination across key markets including the U.S., EU, Japan, China, and others. You will work in close collaboration with manufacturing, quality, clinical development, and regulatory colleagues across all affiliated companies under the Asahi Kasei healthcare umbrella.

Key Tasks and Responsibilities

• Lead global regulatory CMC strategies for products spanning multiple regions.
• Prepare and review high-quality CMC documentation for INDs/IMPDs, NDAs/BLAs/MAAs, and lifecycle updates.
• Serve as the primary CMC regulatory liaison with global health authorities (FDA, EMA, PMDA, MHRA, etc.).
• Collaborate with cross-functional teams to support technology transfers, site changes, and capacity expansions.
• Ensure compliance with global regulatory requirements and monitor regulatory changes.
• Represent Regulatory CMC on project and governance teams.
• Support the integration of systems and processes across the broader Asahi Kasei organization.
• Work closely with external consultants where applicable.

Education and Experience Requirements

We are looking for someone who is curious and motivated to take on a role with significant responsibility and broad cross-functional exposure. In this global position, you will work across various product types and development stages, contributing to programs that span different geographies and regulatory landscapes.

• BS or MS in a life sciences discipline is required; an advanced degree is considered a plus.
• Minimum of 10 years’ experience in regulatory affairs, with at least 5 years specifically in Regulatory CMC strategy.
• Strong knowledge of global regulatory CMC requirements and ICH guidelines.
• Proven track record in preparing and submitting CMC sections for regulatory filings (INDs/IMPDs, BLAs/NDAs/MAAs).
• Experience interacting with health authorities globally (e.g., FDA, EMA, PMDA, MHRA).
• Familiarity with both small molecules and biologics; direct hands-on experience in CMC technical content creation (Module 3, CPD) is highly valuable.
• Excellent communication and interpersonal skills; ability to work collaboratively in a matrixed, global environment.
• Previous experience working with contract manufacturers (CMOs) is preferred.
• Proficiency in MS Office and document management systems such as Veeva.

Reasons to Join the Calliditas Team

• Be part of a growing global organization with innovative therapies in nephrology, immunology, and transplant medicine.
• Work with experienced teams across Sweden, the U.S., and Japan in a dynamic and supportive environment.
• Support both marketed products and an evolving pipeline with multiple development-stage assets.
• Hybrid setup (typically 3 days in office); collaborative culture with supportive leadership.
• Opportunity to shape and grow the Regulatory CMC function in a newly integrated global organization.
• Dedicated, experienced and highly skilled colleagues
• Participate on bonus and benefit programs

Welcome to join the Calliditas Team!