Reg Affairs, LCM, Reg submission in Onco division

- Independent handling of client and projects as and when needed.- To work on and manage assigned projects and ensure required permission within timeline for Drugs/Medical Device/ Cosmetics/ Chemical products.- To proactively approach client for the required documents, manage technical requirements and meet the client’s expectations.- To learn, develop understanding and be updated with worldwide regulatory requirements and support team in finalizing regulatory strategy for new… Show more - Independent handling of client and projects as and when needed.- To work on and manage assigned projects and ensure required permission within timeline for Drugs/Medical Device/ Cosmetics/ Chemical products.- To proactively approach client for the required documents, manage technical requirements and meet the client’s expectations.- To learn, develop understanding and be updated with worldwide regulatory requirements and support team in finalizing regulatory strategy for new proposals.- To achieve timelines as defined and arrange for submission and approval.- To ensure and track the renewal of licences within timeline.- To support UK team for review, preparation, compilation, and submission of new MA application or RFI/ Query responses to MHRA.- To support EU team for life cycle management and LoQs, Renewals, and Variation filings for EU/RoW/ LATAM/ EAEU/ Middle East/ Asia markets.- To support projects in India and enable Client to advocate for upcoming regulations in India.- To empower clients through latest updates in regulations and by preparing presentations and guidance documents. Show less

- To evaluate and finalize regulatory strategy for new projects under development for new drugs ,biologicals, cosmetics.- To handle individual projects, and to manage life cycle of allotted projects.- Compilation and submission of applications of Solid Oral & Biological products in India.- To be responsible for artwork/ labelling/ package insert (Prescribing Information - PI/ SmPC) management, pharmacopoeial compliance as per latest updates.- To manage team for allotted work, to… Show more - To evaluate and finalize regulatory strategy for new projects under development for new drugs ,biologicals, cosmetics.- To handle individual projects, and to manage life cycle of allotted projects.- Compilation and submission of applications of Solid Oral & Biological products in India.- To be responsible for artwork/ labelling/ package insert (Prescribing Information - PI/ SmPC) management, pharmacopoeial compliance as per latest updates.- To manage team for allotted work, to work closely and communicate requirements with cross-functional teams, business team and ensure completion of projects within timeline. Show less

- To evaluate/ review, comment and arrange documents from cross functional teams, to compile and apply to procure Clinical trial, manufacturing & marketing approvals of new projects under drug/ biological/ cosmetic category.- To manage, track and ensure renewal of licences within timeline to avoid any regulatory non-compliance.- To keep close watch over regulatory updates, pharmacopoeial updates and to manage compliance to the latest guidelines published all over world and to ensure… Show more - To evaluate/ review, comment and arrange documents from cross functional teams, to compile and apply to procure Clinical trial, manufacturing & marketing approvals of new projects under drug/ biological/ cosmetic category.- To manage, track and ensure renewal of licences within timeline to avoid any regulatory non-compliance.- To keep close watch over regulatory updates, pharmacopoeial updates and to manage compliance to the latest guidelines published all over world and to ensure implementation of the same.- To evaluate and manage artworks/ prescribing information (SmPC) related activity along with pharmacovigilance support and response to PSUR queries and ensure timely completion. Show less

- To scrutinize, and to prepare NOCs for import [Form-11 (BE/Non-BE)/Dual use NOC], Test licence(Form 29 NOC), Export NOC; applications for WHO-GMP and CoPP of drug products for domestic and international markets.- To prepare, upgrade and manage the SOPs and maintenance of database of CDSCO zonal office in order to comply ISO requirements.- Record keeping, Control and Archival of documents prepared for QMS.

Training on DOT NET, SQL for website designing and production support for US based client.