Deputy Manager – Drug Regulatory Affairs - Gracure Pharmaceutical Ltd. - New Delhi, India
(2024-04)
- To prepare the RA Strategy in collaboration with partners with focus on cost implications for Semi-Regulated market (Malaysia, Thailand, Singapore, Tanzania, Zambia, South Africa, Dominican Republic, Costa Rica, Peru and other ASEAN countries Philippines, Brunei, Vietnam, Cambodia, Myanmar)
- Documents review for TGA filing and CMC for Canada, UK & EU
- NPD issuance and Strategy note preparation
- Documents review for R&D developed projects
- To provide the guidance to team to arrange the documents from different stakeholder and review the documents as per RA adequacy to provide the quality dossier for submission to partner
- To provide the guidance to team to respond the query of partner/ Agency
- Ensure the timely submission of query response to facilitate the approval
- To approve the change control for regulatory adequacy and requirements
- To ensure the lifecycle management of product to smoothen the market supply of the product
- To check the central repository of submission and timely variation and renewal filing for the products sothat supply is not impacted
- API vendor management strategy and facilitation as per management plan
- Timely strategy sheet to management enabling decision making
- Timely filing of API variations enabling no loss in business continuity
- Maintain trackers (new, renewal, variations, queries) and prepare the PPT for regulatory submission
Assistant Manager – Drug Regulatory Affairs - Gracure Pharmaceutical Ltd. - New Delhi, India
(2021-08 - 2024-03)
- To prepare the RA Strategy in collaboration with partners with focus on cost implications for Semi-Regulated market (Malaysia, Thailand, Singapore, Tanzania, Zambia, South Africa, Dominican Republic, Costa Rica, Peru and other ASEAN countries Philippines, Brunei, Vietnam, Cambodia, Myanmar)
- To provide the guidance to team to arrange the documents from different stakeholder and review the documents as per RA adequacy to provide the quality dossier for submission to partner
- To provide the guidance to team to respond the query of partner/ Agency
- Ensure the timely submission of query response to facilitate the approval
- Assess the change control for regulatory adequacy and requirements
- To ensure the lifecycle management of product to smoothen the market supply of the product
- Maintain central repository of submission and timely variation and renewal filing for the products sothat supply is not impacted
- API vendor management strategy and facilitation as per management plan
- Timely strategy sheet to management enabling decision making
- Timely filing of API variations enabling no loss in business continuity
- Maintain trackers (new, renewal, variations, queries) and prepare the PPT for regulatory submission
Team Leader - Drug Regulatory Affairs - Gracure Pharmaceutical Ltd. - New Delhi, India
(2020-05 - 2021-07)
- Timely planning of Fresh dossier for ROW market and discuss strategy for dossier filing
- Review the Dossier and Query response; plant documents for regulatory filing
- Lifecycle management, support harmonization for projects allocated
- Timely variations and renewals
- Filing updated recipes measured by no stop in business continuity /penalty due to delays
- Timely harmonization strategy sheet to management enabling decision making
- API vendor management strategy and facilitation as per management plan
- Timely strategy sheet to management enabling decision making
- Timely filing of API variations enabling no loss in business continuity
- Follow up of timely approvals in collaboration with partners
- Timely tracking of approvals, no delays due to missed communication
- Enable timely recipe preparation and launch information
- Assess available filig expecting approval with operational to facilate no delay in launch
- Update the Trackers such as variation, Portfolio for renewal, Query response tracker, dossier
- Dossier submission; registration status sheet etc.
Sr. Executive – Drug Regulatory Affairs - Gracure Pharmaceutical Ltd. - New Delhi, India
(2013-02 - 2020-04)
Dossier Preparation & reviewing as per ACTD, CTD Guidelines; regional format for following countries: ASEAN Countries (Vietnam, Malaysia, Singapore, Thailand, Cambodia, Philippines, Myanmar), CIS countries (Ukraine, Kyrgyzstan, Moldova, Tajikistan, Armenia and Uzbekistan), African countries (Botswana, Sierra Leone, Nigeria, Kenya, Ethiopia, Zimbabwe, Tanzania), LATAM countries (Peru, Panama, Costa Rica, Chile), and Others (Bhutan, Nepal, Afghanistan)
- Query handling as per dossier preparation and submission
- Reviewing the Drug Master file
- Product Renewal Management (Renewal calendar)
- Documents Notarization and Legalization
- Product Renewal Management (Renewal calendar) and Renewal Portfolio for Product Renewal planning; timely submission
- Maintaining the registration status sheets of all countries and Coordination with clients
- Approval Package Preparation as allocated
- Responsibility of progress sheet updation for all countries and follow-up till dossier submission
- Maintenance of CDA file; other regulatory documents
- Follow-up Single Point Contact-QA and QC sheet or follow-up from plant documentation
- Prepare the monthly QA; QC Summary Sheet and SENSITIZATION MEETING SLIDE to improve the quality documentation
- Variation filing
Executive - Drug Regulatory affairs - Health Biotech Limited Chandigarh - Chandigarh, India
(2011-07 - 2013-01)
- Dossier compilation for semi-regulated markets
- Review the API DMF
- Maintenance of CDA file & other regulatory documents
- Handle the queries related to dossier and COPP
Executive - Drug Regulatory affairs - Ahlcon Parenterals (India) Limited (B. Braun group company) - Bhiwadi (Rajasthan), India
(2010-09 - 2011-07)
- Dossier compilation for semi-regulated & regulated markets
- Review the API DMF
- Handle the queries related to dossier
Executive - Quality Assurance - Gracure Pharmaceuticals Ltd. - Bhiwadi (Rajasthan), India
(2009-06 - 2010-08)
- IPQA
- BMR, BPR preparation
- APQR preparation & other documentation work
Summer Training - Aurochem (I) Pvt. Ltd. - B-74, Sector-2 Noida 201301, India
(2008-06 - 2008-07)
