Balakrishna Nakka

Regulatory Affairs Manager @Lupin Healthcare

London, GB

Preparation, Review and Submission of clinical trial applications including amendments via EU CTIS and MHRA IRAS submissions. Provide regulatory guidance throughout the clinical development lifecycle. Leading project team meetings both internal and external customers. Expert in Part I documents and CMC regulatory including IMPD preparation and review. Support regulatory affairs services with an emphasis on regulatory strategy and the preparation, review and submission of documents to UK and EU markets. Preparation, review and compilation of marketing authorization applications and variations in UK and EU (via national, MRP/DCP and CP procedures). Support post-approval regulatory activities to ensure timely preparation of various documents and studies required by EMA for an EU orphan registered product. Act as point of contact to health authorities. Responsible for submissions in IRIS, XEVMPD, PLM, MIA and WDA portals. Up to date knowledge of recent guidelines and regulations. Knowledge of PIPs and scientific advice. Submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs and their Educational Material. Publishing on eMC.