Senior Principal Consultant, Regulatory Affairs

Senior Principal Consultant, Regulatory Affairs

Cytel

Stockholm or Uppsala, Sweden

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.

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