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REGULATORY SPECIALIST- CTA/IND DEVELOPMENT DELIVERY

Coordinate data collection and reporting process for compliance with timelines for delivery of labelling updates with partners at global, regional, and local levels. Manage data collection, report dissemination, and follow-up for...

CompanyGsk
AddressBengaluru, Karnataka
CategoryFacilities
Date Posted 2 months ago See detail

Regulatory specialist- CTA/IND development delivery

Gsk

Bengaluru, Karnataka

Coordinate data collection and reporting process for compliance with timelines for delivery of labelling updates with partners at global, regional, and local levels. Manage data collection, report dissemination, and follow-up for...

Senior Manager - Business Transformation - Pharma R&D

Gsk

Bengaluru, Karnataka

Understanding the business landscape and priorities to define key strengths and improvement areas. Framing complex problems and develop recommendations based on our business knowledge and analysis. Ownership in translating recomm...

Assistant Manager / Executive - Operational Quality

Gsk

Nashik, Maharashtra

Ensures compliance and inspection readiness. Ensure right first time line clearance. Ensures that the activities on shop floor are in compliance with regulatory and QMS requirements. Ensures timely compliance to all audit observat...

Sr. Manager System & Compliance

Gsk

Mumbai, Maharashtra

This is key role to lead system related activities within W&D in collaboration with Commercial, Finance and Quality. This role will be SPOC for developing develop ERP related SOPs, ensuring SOD compliance for entire India CSC func...

Statistician, Clinical Trial Transparency

Gsk

Bengaluru, Karnataka

Provide appropriate guidance to project statisticians to ensure all required data needed for disclosure is generated through review of the Statistical Analysis Plan and TFL (Tables, Figures & listings). Maintain awareness of chang...

Associate Director, PV Ops – Optimization and Engagement

Gsk

Bengaluru, Karnataka

Contribute to creation or development of PV Ops processes and written standards. Collaborate with stakeholders (e.g., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operation...

Senior Principal MDM Technical Architect (Integrations)

Gsk

Bangalore, Karnataka

Design, develop, and implement master data management solutions using the latest tools and technologies. (SAP MDG, Reltio, Informatica etc.). High collaboration & partnership with Technical and Business Process teams to design, do...

Associate Director, Study Delivery

Gsk

Bengaluru, Karnataka

Manages and leads a group of SMs and SDSs across the entire GSK pipeline within the Global Clinical Delivery Management.. Recruits, retains, leads and develops team members. Leads and directs staff by providing key objectives, ali...

Transparency Specialist 2

Gsk

Bengaluru, Karnataka

The role is responsible to ensure consistent, timely and complete delivery of clinical documents and data related to GSK Sponsored human subject research e.g. protocol and results summaries, full protocols, reporting and analysis...

Manager, Data Management

Gsk

Bengaluru, Karnataka

Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines Devel...

Senior Literature Specialist

Gsk

Bengaluru, Karnataka

Mentoring and training new team members on literature review process as requiredCompetencies: Minimum level of job-related experience required: 7 to 11 years of relevant industry experience Pharmaceutical industry experience...

Principal Cloud Security Assurance

Gsk

Bengaluru, Karnataka

Ensure all Cloud Security Assurance services are delivered within agreed timelines.. As services transition to BAU, ensure appropriate resourcing for the service and identify improvements as necessary. . Engage with senior stakeho...