submission lead
3 weeks ago
his role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices
May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc)
May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets
May be required to lead or participate to process improvement initiatives
May be required to take on additional Project Management responsibilities if identified as Single Point of Contact (SPOC) for the GRL
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CTA IND Submission Lead
2 weeks ago
Bengaluru, Karnataka, India GSK Full time ₹ 12,00,000 - ₹ 36,00,000 per yearSite Name: Bengaluru Luxor North TowerPosted Date: Sep Key Responsibilities -Leveraging detailed submission requirement knowledge and technical capabilities to deliver fit for purpose and quality submission packages per agreed schedules. Preparation of Clinical Trial Application (CTA) packages (EU & Non-EU) including authoring of the EU Application forms...
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CTA IND Submission Lead
2 weeks ago
Bengaluru, Karnataka, India GSK Full time ₹ 15,00,000 - ₹ 25,00,000 per yearKey Responsibilities -Leveraging detailed submission requirement knowledge and technical capabilities to deliver fit for purpose and quality submission packages per agreed schedules.Preparation of Clinical Trial Application (CTA) packages (EU & Non-EU) including authoring of the EU Application forms and Market Specific documents, and compilation with other...
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Submission Specialist
2 weeks ago
Bengaluru, Karnataka, India Annalect Full time ₹ 9,00,000 - ₹ 12,00,000 per yearOverview:About Role:We have an exciting role of Submission Specialist (MLR+EMA)to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies.About Omnicom Global SolutionsOmnicom Global Solutions (OGS) is...
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Bengaluru, Karnataka, India GSK Full timeBusiness IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture...
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Bengaluru, Karnataka, India GSK Full timeSite Name: India - Karnataka - Bengaluru, Egypt - Cairo, Poznan GrunwaldzkaPosted Date: Oct Business IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune...
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Bengaluru, India GlaxoSmithKline Pte Ltd Full timeJob Description Site Name: India - Karnataka - Bengaluru, Egypt - Cairo, Poznan Grunwaldzka Posted Date: Oct 21 2025 Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our...
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Bengaluru, Karnataka, India GSK Full timeNazwa biura: India - Karnataka - Bengaluru, Egypt - Cairo, Poznan GrunwaldzkaPosted Date: Oct Business IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune...
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Submission Specialist
1 week ago
Bengaluru, India Omnicom Full timeAbout Omnicom Global SolutionsOmnicom Global Solutions is an integral part of Omnicom Group, a leading global marketing and corporate communications company. Omnicom's branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations...
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Submission Specialist
1 week ago
Bengaluru, India Omnicom Health Full timeAbout Omnicom Global SolutionsOmnicom Global Solutions is an integral part of Omnicom Group, a leading global marketing and corporate communications company. Omnicom's branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations...
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Submission specialist
1 week ago
Bengaluru, India Omnicom Health Full timeAbout Omnicom Global SolutionsOmnicom Global Solutions is an integral part of Omnicom Group, a leading global marketing and corporate communications company. Omnicom's branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations...
