Rahul S. Email and Phone Number

• Accountable for management of the labelling process and labelling development globally.• Leads labelling strategy by providing labelling expertise (labelling regulations, internal processes, and impact analysis of competitor profiles) for EU/UK SmPC’s (Mutual Recognition / Decentralized/National Procedures) and National phases for initial MAA and post approval activities. • Spoke person for UK/EU authorities for resolution of regulatory and scientific issues for initial as well as post-approval safety updates. • Accountable for Renewal application and Sunset clause monitoring and filing• Review, author and assess the product information (SmPC and PIL) against HA safety triggers, Quality Review of Documents (QRD), PRAC recommendations, referral procedures and innovator labels etc to up-to-date labels.• Working closely with business development team and project managers for business growth by supporting commercialization activities and leading the projects for MA transfer activities.• Manage direct reports, interview, and motivate within the Labelling team by providing trainings.• Review and provide input on Standard Operation Procedures (SOPs), Work Instructions and establish training protocols.• Quality management - Supports Significant Investigations/Fact Finding activities and shares information to ensure continuous improvement. Assists in managing Corrective and Preventative Actions (CAPAs) to ensure timely completion and collects CAPA evidence.

Prepare, review and submit labeling for ANDA’s, supplements, ANDS’s, SANDs and amendment in eCTD formats.Plan, coordinates, authors and critically reviews submissions to FDA ensuring that internal consistency and consistency to relevant FDA guidelines are met.Responsible for all drug-listing activities including submission of SPL files via FDA electronic submission gateway (ESG). Independently handling submissions include: ANDAs, Supplements, Annual Reports, and Amendments (complete responses, Discipline review letter, information requested, easily corrected deficiency etc.).Ensuring that all regulatory due dates for regulatory milestones, in support of both pre and post approval submission are met.Working on and solves increasingly complex projects/problems where analysis of the situation or data required evaluation of intangible factors.Responsible for the maintenance and timely completion of regulatory labelling documents to support regulatory complianceEnsuring regulatory flies and data systems are maintained and in compliance related work instructions and regulations.Responsible for all drug-listing activities including submission of SPL files via FDA electronic submission gateway (ESG).

•Artwork Management System- Creation, review & approval of Artworks for domestic & export product e.g FWA, CACIS, ROA, REXP and ROW etc.•Response to the regulatory agencies within the adequate time frames.•Preparation of clear, accessible product labels, PIL’s & artwork.•Support the demand planning team to indent to materials for next month planning.•Investigation of labeling related market complaints, implementation of corrective and preventive actions as required & ensuring Quality compliance as basis for all developments. •Creation, review, approval of change control and ensure closure of Change controls, investigation and deviation in CQMS•Ensure to implement the changes initiated as per regulatory & management requirement on time.•Resource planning / Work assignment / Job allocation

M Pharmacy Research project under taken at Medical Chemistry,New Drug Discovery Research,Ranbaxy Ltd Gurgaon.Project title: Synthesis of Intermediate for Biological active molecules.-Setup and handling of reactions like Protection and De-protection of Amine & Carboxylic acid, Amide Formation, Reduction, and Alkylation. -Isolation and Purification of Compounds by Column chromatography (Polar and Non-Polar).-Characterization & Identification of compound with the help of NMR, Mass spectroscopy and IR spectroscopy.