Arihant Pradhan

Regulatory Affairs (Operations) Consultant @精鼎医药

ON, CA

As a Regulatory Operations Consultant at Parexel, I lead and support global regulatory submissions across multiple markets, ensuring compliance with health authority regulations and delivering high-quality eCTD and non-eCTD submissions. I bring deep technical expertise in regulatory operations, combined with strong project coordination, client management, and team leadership skills.Key Responsibilities:Plan, compile, publish, and submit electronic regulatory applications (eCTD/non-eCTD) for global markets: FDA, EMA, Health Canada, Australia (TGA), GCC, Swaziland, and others.Handle full range of submission types: IND, NDA, ANDA, CTA, sNDA, MAA, BLA, DMF, and post-approval lifecycle activities (supplements, amendments, query responses).Ensure submission documents meet ICH, regional, and internal standards; manage document compliance and formatting using industry tools.Project & Team Leadership:Typically work within a collaborative team environment; also manage independent tasks within technical areas of expertise.Serve as Work Stream Lead on large-scale regulatory projects; function as main client contact and ensure timely, accurate reporting and deliverables.Ensure projects operate within defined scope, timeline, and budget; manage financial forecasts and compliance with contractual terms.Proactively identify project risks, escalate issues, and implement mitigation strategies; ensure training compliance for all project team members.Identify new opportunities via Change in Scope or add-on business, supporting account growth and client satisfaction.Operational Excellence & Continuous Improvement:Demonstrate strong prioritization and problem-solving skills; define clear steps to meet project outcomes.Capitalize on lessons learned from previous projects and internal resources to improve delivery and efficiency.Produce high-quality deliverables that meet client and internal expectations; provide input to improve project processes and outcomes.

Regulatory Affairs Professionals Society

Regulatory Affairs Certificate: Pharmaceuticals

Rajiv Gandhi Prodyogiki Vishwavidyalaya

B.Pharm