Prashant Shroff Email & Phone Number

Vadodara, Gj, In

Bengaluru, Karnataka, India

Reg Affairs, LCM, Reg submission in Onco division

India

- 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

Vadodara Area, India

- 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

Vadodara Area, India

- 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

Ahmedabad Area, India

- 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.

Kolkata Area, India And Chennai, India

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

Master Of Pharmacy, Regulatory Affairs

Master Of Pharmacy, Medicinal And Pharmaceutical Chemistry, Distinction

Activities and Societies: • Executive committee member of PHARMAVISION magazine. (2011) • Attended a seminar on introduction.

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Sciences, First Class

Activities and Societies: Cocurricular activities like - Group Dicussion, Winner in Chess, Member of a cricket team. *Attended AIDS.

Higher Secondary, Science