European Union Regulatory Affairs, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
Manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactics.
With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects
Manage the assembly and timely submission of INDs, NDAs, MAAs and other dossiers as required for investigation and registration of Albireo products in the US and abroad
Ensure regulatory submissions are maintained in compliance with regulatory requirements
Represent the company in its dealings with the FDA and other regulatory authorities as appropriate
Participate on project teams and provide expertise on regulatory matters
Develop and maintain current regulatory knowledge and advise management of significant developments
Manage and develop regulatory staff as appropriate
Bachelor’s degree or higher
6-8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
Experience and knowledge in preparation of INDs, NDAs, and supportive amendments and supplements. Experience with CTD/eCTD mandatory
Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function
Experience with EU submissions is a plus
Working knowledge of GMP, GLP and GCP regulations as well an understanding of the pharmaceutical product life cycle
Working knowledge of regulations related to drug development
Outstanding written and verbal communication skills
Internal Number: 101
About Albireo Pharma Inc.
Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver or gastrointestinal diseases and disorders. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. We were spun out from AstraZeneca in 2008.