Registered member

• Jul 2021 - Present

Head Regulatory Intelligence and Reporting

• Jun 2021 - Present

Manager- Regulatory Intelligence

• Apr 2014 - Jun 2021

Regulatory Intelligence -Manager - optimizing the use of regulatory requirements and intelligence to define and manage the strategic direction for quality global development and lifecycle management to achieve commercial objectives- Monitor trends and upcoming changes in the regulatory environment and evaluate their impact on the business- Regulatory Operational Excellence-- Involved in RA Strategy planning. Maintaining Monthly Business Report for RA department. - Involved in understanding the overall performance for the Regulatory department and suggesting steps to upgrade the same. - Worked with Mckinsey Company as project - for Process improvement an optimization within Regulatory department. - Evaluating the process in RA. Design and implementation support for processes- Variation management and Change control. For these processes recommend and implement the process map, roles/accountability, tools/ templates, checklists etc. required to improve/ sustain the process.- Provide strategic regulatory input and responsible for identifying risks and opportunities and providing recommendations on how to mitigate said risks and maximize said opportunities.

Regulatory Affairs - Europe

• Dec 2009 - Mar 2014

 Responsible for compilation and review of quality submissions for MAAs in EU by Centralized/ National/ DC/ MR Procedures in a timely and accurate manner.  CTD submissions and e-CTD submissions- Responsible for coordination & preparation of regulatory submissions and strategies including product registration, renewals, Variations & product life cycle maintenance in EU market. Life Cycle Management- Responsible for maintaining marketing authorisations and for creating regulatory Variation packages, and submission through MHRA Portal. Represent Regulatory Affairs in multi-disciplinary project teams  Responsible for preparation, filing, and maintenance of all regulatory submissions including original applications, amendments/ supplements/variations and responses to deficiency letters through MHRA portal.  Handling MAA, Duplicates MAs, Piggy Applications, Change of owner ships(COA). Handling IMPD submission to MHRA UK Provide regulatory status to BD. To evaluate the BD proposals for new submissions.  Manage customers and deal with Regulatory consultants and Regulatory agencies.  Participating in project kick-off meetings and taking the project further till regulatory submissions.  Assist – Commercial team. Evaluate new Unit proposals for changes and variations. Review of documents- specifications/ protocols.  Co- ordinate with various departments- R& D, ADL, QA, QC & Production to obtain essential scientific data and error-free documents required for regulatory submissions and to prepare deficiency responses ahead of target timelines. Responsible for preparation of regulatory responses and requests from health authorities and meet aggressive deadlines to ensure that regulatory Agencies receive timely and scientifically robust submissions.  Develop & maintain regulatory knowledge of European regulations.

Executive RA

• Oct 2008 - Nov 2009

QA and RA Executive

• Jun 2006 - Oct 2008