Omkar Arthamwar

Regulatory Affairs Specialist

Role: Regulatory Affairs Specialist at Tata Consultancy Services
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

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Experience

Regulatory Affairs Specialist
Tata Consultancy Services
Mar 2024 — Present
Supervising submission, which include a publishing request from the initial phase to dispatch and archival into repository • Assembly and validating electronic submission for different market such as APAC, US, EU and Canada • Experience in publishing, assembly and validating eCTD dossier for the US market • Publishing submission including ANDA, IND, BLA, DMF and NDA applications and submitting them to CDER and CBER through the ESG portal.Processed marketing authorization application (MAA) submissions to EU national, mutual • recognition procedure (MRP), centralized procedure (CP) and decentralized procedure (DP) with initial, response and variation (type 1A and 1B) • Efficiently managing regulatory documentation to meet electronic publishing standards, • health authority (HA) guidelines and adhering to standard operating procedure (SOPs) • Familiar with all modules (modules 1 to 5) and ICH guidelines (Quality, Safety, Efficiency, Multidisciplinary

Education

Swami Ramanand Teerth Marathwada University
Bachelor of Pharmacy - BPharm, Bachelor of Pharmacy

Contact information

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Work email
•••••@tcs.com
Personal email
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Current company

Tata Consultancy Services

IT Services and IT Consulting · 726K employees · Founded 1968 · Mumbai, India

Tata Consultancy Services (TCS) is the technology partner of choice for industry leading organizations worldwide. Since its inception in 1968, TCS has upheld the highest standards of innovation, engineering excellence, and customer service. It has set an aspiration to become the world's largest AI-led technology services company and is enabling its clients to transform themselves across the full AI stack, from infrastructure to intelligence. Rooted in the heritage of the Tata Group, TCS is focused on creating long term value for its clients, its investors, its employees, and the community at large. With a highly skilled workforce spread across 55 countries and 202 service delivery centers across the world, the company has been recognized as a top employer in six continents. With the ability to rapidly apply and scale new technologies, the company has built long term partnerships with its clients – helping them emerge as perpetually adaptive enterprises. Many of these relationships have endured into decades and navigated every technology cycle, from mainframes in the 1970s to artificial intelligence today. TCS sponsors 14 of the world’s most prestigious marathons and endurance events, including the TCS New York City Marathon, TCS London Marathon and TCS Sydney Marathon with a focus on promoting health, sustainability, and community empowerment. Caution against fraudulent job offers: TCS doesn’t charge any fee throughout the recruitment process. Refer here: https://www.tcs.com/careers/india/recruitment-fraud-alert

tcs.com

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Experience

Regulatory Affairs Specialist

Education

Swami Ramanand Teerth Marathwada University

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