Senior Principal Consultant, Regulatory Affairs

 

Experience/qualifications

• 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