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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. Albireo has deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs.
Albireo is developing Odevixibat initially to treat patients with PFIC, a rare genetic liver disease, and plans to consider additional development in other pediatric cholestatic liver diseases and disorders in the future. Our Phase 3 program in PFIC includes a single randomized, double-blind, placebo controlled, multicenter clinical trial and an open-label long-term extension study. The double-blind trial, called PEDFIC1, is underway with data read out anticipated in mid- 2020.
The U.S. Food and Drug Administration (FDA) has granted to the Odevixibat PFIC program or elements of its fast track, rare pediatric disease and orphan drug designations. The European Medicines Agency (EMA) has granted Odevixibat orphan designation, as well as access to the Priority Medicine’s (PRIME) scheme for the treatment of PFIC. Its Pediatric Committee has agreed to Albireo's Odevixibat Pediatric Investigation Plan for PFIC. Both FDA and EMA also have granted orphan drug designation to Odevixibat for the treatment of Alagille syndrome and primary biliary cholangitis. Albireo will commercialize Odevixibat in the US, Europe & Canada and is pursuing potential partners in remaining regions.
We are seeking an experienced, in-house Regulatory Operations professional who can assist with a variety of submissions and records management activities with limited supervision. In this position, you will participate in various activities as part of a dynamic and evolving Regulatory Operations team. The Senior Associate must be a creative, resourceful, integrative thinker.
Roles and Responsibilities
Independently prepare and submit eCTD and non-eCTD submissions of varying complexity to IND/CTA and NDA/MAA applications
Format MS Word and Adobe Acrobat files to a state of submission-readiness
Act as department liaison to publishing and archival vendors
Provide support to Regulatory Affairs and other
Project stakeholders in the creation of submissions documents
Manage and maintain correspondence and other records in regulatory tracking system
Coordinate exchange of records using document-sharing platforms
Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement associated process improvements
Maintain current regulatory knowledge and keeps abreast of regulatory procedures and changes related to the electronic Common Technical Documents.
Expert-level document formatting and submissionbuilding (eCTD and non-eCTD)
Expert-level knowledge of PDF Publishing tool(ToolBox preferred)
Proficiency in Microsoft Word, Microsoft Excel,
Acrobat Professional, and Sharepoint
Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
Excellent organization, written/verbal communication, and attention to detail
Grouped and OPDP Submission experience
3 to 5 years of relevant Regulatory Operations experience in biotech/pharmaceutical industry
Strong understanding of submission requirements,
Records management concepts, and electronic tools and systems.
Bachelor’s degree or equivalent experience
Internal Number: 1033
About Albireo Pharma
Albireo is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver 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.