Advanced degree in life sciences or related field (PhD, PharmD or MSc or equivalent)
Minimum of 10 years of experience in regulatory affairs within the pharmaceutical and/or biotech industry
Solid experience of strategic regulatory affairs in drug development phase (Phase I-III)
Advanced understanding of regulatory requirements (EMA and FDA)
Experience of regulatory authority interactions (EMA and FDA)
Experience of regulatory submissions; authoring and compilation of e.g. briefing documents, IND, IMPD, IB, ODD, PIP, PSP, MAA/NDA, and related regulatory documentation
Solid understanding and experience of building regulatory strategies; regulatory roadmaps/TPP/TPC/CDS
Experience with compilation of label/USPI is meriting
Excellent communication and project management skills, with the ability to interact effectively with cross-functional project teams, clients and regulatory authorities
Fluency in English, both written and verbal
Job description
Lead and execute regulatory strategies and submissions to support clients according to their product development programs
Develop strategic documentation such as regulatory road maps, regulatory gap analyses, feasibility assessments, regulatory due diligence, and Target Product Profile (TPP)’s/TPCs/CDSs for clients
Support, manage and lead scientific advice meetings and communication with regulatory authorities
Coordinate and compile regulatory submissions, which entail leading cross-functional teams including clinical, nonclinical and CMC to ensure alignment with regulatory strategies
Author and review regulatory documentation, e.g. briefing documents, IND, IMPD, IB, ODD, PIP, PSP, and MAA/NDA
Act as primary contact towards the clients and as project manager for the assignment, working closely with the client/Cytel Sweden project team members as well as other external cross-functional team members within the projects
Monitor regulatory intelligence and provide clients with insights into current standards, guideline updates and authority expectations
Educate others within Regulatory Affairs – externally and internally
Continuously and proactively improve internal processes and ways of working
Support sales activities such as client meetings and events as subject matter expert
Senior Principal Consultant, Regulatory Affairs