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. We have our headquarters in Stockholm, Sweden and offices in the USA, Switzerland and France.
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®. Additionally, 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).
As a CMC Documentation Manager you will be a key member of the Pharmaceutical Development Project Team. In this role you will be accountable for leading the generation and delivery of CMC sections of regulatory documents e.g. marketing and clinical study applications, post-approval changes as well as responses to Health Authority questions and briefing documents. The team (PDM) is also accountable for delivering innovate design and efficient and robust processes for the manufacture of Calliditas’ drug substances and drug products.
Key tasks and responsibilities
- Defining which CMC documents are required in cooperation with Regulatory Affairs and the Pharmaceutical project team.
- Managing and building CMC regulatory submissions for clinical trial and marketing applications as well as for change applications/variations in accordance with current standards and processes using agreed tools.
- Preparing CMC sections of regulatory submissions.
- Generating CMC-documents and supporting experts in the creation of CMC-documents (CMC-“Technical Writer”).
- Coordinating the assembly of technical responses to inquiries from Global Health Authorities.
- Supporting the review, revision, verification, and approval process of the CMC sections.
- Acting as a CMC Documentation lead on multiple projects with varying levels of complexity, timelines, and deliverables.
- Accountable for the technical quality and delivery of all CMC submissions and ensuring regulatory compliance and quality requirements are met by reviewing CMC-documents.
- Generate quality overall summaries/expert statements for above mentioned submissions to Health Authorities.
- Accountability for PDMs document management, including regulatory CMC-documents as well as internal documents.
Calliditas is looking for a person who has a broad experience within the pharmaceutical industry and who wants to continue developing skills within a fast-growing international company. You need the ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple development programs simultaneously.
You are able to solve problems using innovative thinking and good decision making. You are highly organized and have a structured and analytical way of working.
- A minimum of 5-8 years' experience in the pharmaceutical industry within relevant roles (e.g. in pharmaceutical production, quality control, development, regulatory affairs) and/or within the GMP environment.
- Bachelor or master's degree in chemistry, biochemistry, biochemical engineering, pharmacy or related fields.
- Good understanding of the pharmaceutical industry, including drug development, manufacturing and regulatory requirements.
- Solid experience in authoring of CMC submissions.
- Excellent verbal and written communication skills in English.
- Good project management skills and the ability to focus on multiple issues at the same time.
- Expertise in using Document Management Systems for document preparation and management.
- Skilled in building relationships with both customers and collaborating within the team.
- Ability to lead change and drive for results.
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
Welcome to join the Calliditas Team!