Nagarajan Periasamy Email & Phone Number

• Extensive experience from Pfizer Global Regulatory Affairs (Non-CMC) team.• Proven track record of managing complex regulatory issues and experience in developing Global Regulatory Strategy Document (GRSD)/Global Regulatory Plan (GRP) for risk register and mitigation, briefing and scientific advice documents to align, manage and implement the global regulatory strategies throughout the product lifecycle.• Track record of content development, harmonization, review, approval, and maintenance of Global Product Information (CDS), EU common labels (CP, MRP/DCP SmPC and PIL), and Instruction for Use (IFU), for assigned products including medical device and combination products. • Solid knowledge in Drug Development process including orphan drugs, regulatory strategy (clinical, safety and non-clinical) and pharmaceutical labelling support for initial registration and post approval phase in EU and EM regions.• Experience in people and project management, adoption/change management, leadership, and mentorship to direct and indirect reports.• Track record of partnering, leading, and delivering through others in a highly matrix organisation/global team with tight timelines.• Dynamic and self-motivated individual and have strong analytical, problem-solving, project, time management skills.• Good collaborator with inherent people skills.

Listed skills include Regulatory Affairs, Cmc And Strategy Driven Submissions, Psur And Pbrer Submissions, Pan European Submisisons, and 13 others.