Riddhi Tandel

Regulatory Affairs Officer @Fresenius Kabi

Runcorn, GB

As a Regulatory Affairs Officer at Fresenius Kabi, I supported UK and Ireland regulatory operations for a diverse product portfolio, including generics, biosimilars, oncological drugs, and parenteral nutrition products. I worked across the full regulatory lifecycle—from initial submission to post-approval variations and renewals—ensuring full compliance with MHRA and HPRA requirements. Key Responsibilities:Prepared and submitted Type IA/IB and Type II variation dossiers, renewals, and Article 61(3) notifications via eCTD format.Drafted and reviewed labeling components (SmPC, PIL, and mock-ups) in alignment with QRD templates; collaborated on PPM (Product Packaging Materials) development and approval.Managed RFI responses from MHRA, ensuring compliance with regulatory timelines and content accuracy.Supported post-Brexit regulatory operations, including UK Standalone and Great Britain-specific submissions.Handled sunset clause notifications, withdrawal procedures, and Certificate of Pharmaceutical Product (CPP) requests.Performed regulatory gap analyses for legacy products to identify and resolve compliance risks.Provided regulatory input into artwork review and approval workflows, ensuring content met latest guidelines.Engaged in regulatory intelligence to stay updated on changing EU/UK legislation and guidance.Collaborated cross-functionally with QA, packaging, RA labeling, and global RA teams.

Gujarat Technological University (GTU)

Master of pharmacy , Pharmaceutical regulatory affairs