Hire Talented Regulatory Affairs Associates / Coordinators

Regulatory Affairs Specialist

Rahul Mishra is a Regulatory Affairs Specialist with over 12 years of experience in global drug product registrations and lifecycle management across Europe/UK, Latin America, ASEAN, CIS, and African markets. He has strong expertise in CMC documentation, CTD/eCTD dossier preparation, regulatory publishing, and post-approval submissions. Skilled in interpreting and applying international regulatory guidelines (ICH, EMA), Rahul collaborates closely with cross-functional teams to ensure compliance and timely approvals. Known for providing regulatory strategy, leading submission planning, and resolving health authority queries efficiently, he drives smooth regulatory operations and supports successful product commercialization in global markets

Regulatory Affairs Specialist

Shwetha Tiwari is a Regulatory Affairs Specialist with over 8 years of experience in global pharmaceutical regulatory operations, specializing in CMC documentation, dossier compilation, and product lifecycle management. She has extensive expertise in managing international submissions, handling variation filings, coordinating health authority responses, and supporting regulatory audits across multiple regions. Skilled in working with cross-functional teams including QA, QC, R&D, and Production, Shwetha ensures regulatory compliance with ICH, CTD, GMP, and country-specific guidelines. Known for her strong documentation accuracy, process ownership, and team mentorship, she contributes to efficient product registration, compliance assurance, and continuous regulatory improvement.

Senior Executive – Regulatory Affairs

U. Bhavna is a Regulatory Affairs Senior Executive with over 9 years of experience in managing regulatory submissions, dossier compilation, and CMC documentation for injectable and oral solid dosage formulations. She specializes in ANDA and CTD submissions, analytical and manufacturing document review, stability data assessment, and post-approval lifecycle management. Skilled in regulatory compliance across USFDA, EU, and WHO guidelines, Bhavna effectively coordinates with cross-functional teams to ensure timely submissions and approvals. Her strong technical acumen, audit experience, and proactive problem-solving approach contribute to achieving successful regulatory outcomes in global markets.

Senior Executive – Regulatory Affairs

Rohan Mishra is a Regulatory Affairs Specialist with over 13 years of experience in managing global product registrations, dossier submissions, and regulatory compliance for pharmaceutical formulations. He excels in compiling and reviewing CTD, ACTD, and country-specific dossiers for solid and injectable products, ensuring timely approvals and adherence to international standards. Skilled in cross-functional coordination, artwork review, and document control, Rohan effectively collaborates with QA, QC, and production teams to streamline regulatory operations. Committed to maintaining quality and compliance, he leverages his technical expertise to support successful market authorizations and lifecycle management across diverse geographies.

Arjun Verma

Arjun Verma is a Regulatory Affairs Specialist with 9 years of experience in global regulatory compliance, submissions, and post-approval lifecycle management within the pharmaceutical industry. he excels in managing variation and renewal submissions, coordinating with cross-functional teams, and ensuring timely delivery of high-quality regulatory documentation. Skilled in CTD/eCTD preparation, CCDS review, and RIMS data integrity, demonstrates a proactive approach to problem-solving and strategic planning. Recognized for precision, accountability, and innovation, he was honored as Innovation Champion – Q2 2024 for her contributions to process optimization and regulatory excellence.