Job title: Executive – Regulatory Affairs

Company: GlaxoSmithKline

Job description: Job Description : Site Name: India – Maharashtra – Worli Mumbai Posted Date: Jul 1 2022 Is there any greater challenge than getting ahead of disease? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, bec

Job Description : Site Name: India – Maharashtra – Worli Mumbai Posted Date: Jul 1 2022 Is there any greater challenge than getting ahead of disease At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact stronger and more sustainable shareholder returns and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster accountable for impact – with clear ownership of goals and support to succeed and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Responsibilities: 1. Assist the Regulatory Affairs Manager in fulfilling regulatory responsibilities for activities related to Clinical Trials and its lifecycle management of Pharmaceuticals, Biopharm and Vaccine assets for India. 2. Compile Regulatory Dossiers for: Clinical Trial Applications (Phase Ib/II/III/PMS) – Global pipeline assets Clinical Trial Applications – local Phase 3 and Phase 4 studies to support registration Central Drug Laboratory (CDL) Applications for Clinical Trial Lot releases for vaccine assets Maintenance Applications- Protocol amendments, Compliance Notifications in line with NDCT Rules 2019, CT Variations Clinical Trial Post approval commitments 3. Review and approval of CT labels in line with NDCT Rules 2019 4. Liaise with Global Regulatory Affairs (GRA) team for Regulatory requirements of various submission activities 5. Ensure regulatory compliance to requirements of Drugs and Cosmetics Rules especially NDCT Rules for GSK studies approved by DCGI. 6. Tracking of Projects: Track and maintain the local XL database for the projects assigned E2E management of CT related submissions, its status & archival on GSK Global RA Systems At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. .LI-GSK Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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Expected salary:

Location: Mumbai, Maharashtra

Job date: Mon, 04 Jul 2022 22:55:16 GMT

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