Manager Regulatory Affairs

• Jun 2022 - Present

-Prepared regulatory submissions (EU/UK Dossier, Variation Package & deficiency response) compilation, review & publication in the e-CTD framework. - Orchestrated the regulatory strategies for new product development and provided strategic, scientific, and regulatory inputs for CMC and procedural aspects. - Performed review of development and submission batches docs. - Identified gaps and formulated process improvement plans by working collaboratively with the leadership team, resulting in improved organizational productivity and efficient business operations. - Involve in the product launch activity in EU/UK, guiding the cross-functionally for the same. - Involve in the finalisation of BR/BT site, and PV service provide. - Involve in the QP audit at the API/intermediate manufacturing site. Show less

Senior Manager Regulatory Affairs & Project Management

• Apr 2021 - Jul 2023

• Prepared regulatory submissions (ANDA, amendments & supplements) compilation, review and publication in e‐CTD framework. • Orchestrated the regulatory strategies for new product development and provided strategic, scientific and regulatory inputs for CMC and procedural aspects. • Performed review of development and submission batches docs, in addition to review and finalization of technology transfer docs. • Planned, coordinated, and directed Regulatory Affairs programs, to ensure continuous process improvement in compliance with current Regulatory guidelines. • Identified gaps and formulated process improvement plans by working collaboratively with the leadership team, resulting in improved organizational productivity and efficient business operations. • Collaborated cross-functionally and maintained seamless communication between internal / external stakeholders, ensuring business deliverables are met. • Headed the RA program including on-going development and implementation, and maintenance. • Directed Regulatory Affairs team leading to high quality project deliverables and minimized non- conformance issues. • Regulated and supervised the audit functions to monitor the compliance of processes as per current Regulatory requirements. • Participated in the monthly Operational Meetings to review KPI, while overseeing the budget and capital plans for the projects. • Led the RA/PM team and consistently met key business deliverables through ongoing coaching, feedback and mentorship sessions. Show less

Manager Regulatory Affairs

• Sep 2020 - Mar 2021

• Acted as a Functional CMC Representative for Europe, Asia, Africa, Latin America and Middle East (GCC), while ensuring compliance as per the regulatory norms/requirements. • Crafted a CMC plan for the timely identification of New Drug Product for the European market. • Maintained regulatory submission files in accordance with the ICH and regulatory requirements. • Executed European CTD compilation of the products for DCP filling (Technical Review, Regulatory compilation & submission). • Enabled compilation and review of dossiers for European market for DCP procedure, MRP procedure and National Submission. Show less

Senior Manager Regulatory Affairs & Project Management

• May 2018 - Jun 2020

• Handled EDQM (October 2018) & USFDA (January 2019) audits with zero observations. • Facilitated with Functional Experts to provide timely answers to CMC queries from regulatory agencies. • Served as a Functional CMC Representative on assigned New Drug Substance/New Drug Product Teams. • Devised risk mitigation plan & effectively communicated the project status to the clients as well as project heads. • Designed, executed and delivered projects within time and budget constraints, while ensuring alignment with the project scope. • Conducted regulatory review of production modifications within the change control structure and submitted plan advice to the Department of Technical Operations and Performance (Drug Substances/Drug Product). Show less

Deputy Manager

• Jul 2008 - May 2018

• Navigated multi-function teams and implemented strategic business plans, ensuring alignment to corporate goals. • In-charge of compilation and review of dossiers for US (ANDA) & Europe market (DCP, MRP & National submission). • Initiated end-to-end regulatory compliance, including regulatory strategies‐submissions, timelines, and decisions on RLDs. • Ensured timely submission of technical data to queries received from Regulatory Authorities for under‐ registration products. • Supervised the compilation and review of variation package for Europe market as per variation guidelines (DCP, MRP & National). • Undertook planning, execution and maintenance of emerging markets Registration Dossiers, Re‐Registration Dossiers and Company Registration Dossiers. • Conceptualized regulatory strategies for new product development as well as provided strategic, scientific, and regulatory inputs for CMC and procedural aspects. • Performed the review of development and submission batches documents including analytical method validation protocols and reports, product development reports, specifications, and batch manufacturing records. • Coordinated and worked cross-functionally with International Marketing, R&D, Quality Assurance, Production, Contract Manufacturing Sites and Supply Chain for timely project delivery. • Engaged in compilation & review of DMF for US, EU, EDQM, Canada, Australia and international markets (Asia, Africa, Latam etc.) while ensuring strict compliance to the governing rules/regulations. Show less

Regulatory Affairs Officer

• Jul 2007 - Jul 2008

Junior Development Scientis

• Mar 2007 - Jun 2007

Junior Quality Assurance Chemist

• Jan 2006 - Mar 2007