GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Post : Regulatory associate manager-I/ II / III-CTA/IND development delivery
Job Description
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• A good understanding of Clinical Trial Directive, DIA TMF Reference Model and CTA/IND submission requirements for multiple countries/submission types
• Responsible for: coordination, development, refinement of the CTA/IND lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures.
• Accountable to the CTA Team Manager for overall work plans, accountable to individual GRLs/TGs for study submission planning & delivery status.
• Accountability for agreed tasks and projects.
• Ensure independent communication, with a range of internal GSK staff, in supporting achievement of the assigned goals.
• Ensure quality of both own and submission team’s work, delivering to agreed timeframes, including compliance with GSK systems and record keeping.
• Provide input to internal processes and written standards.
• To work flexibly to meet constant shifting priorities and timelines
• May provide support to other activities within the CTA/IND and/or Content Delivery Team.
Candidate Profile
5 years of relevant experience
Additional Information
Experience : 5 years of relevant experience
Location : Bengaluru Luxor North Tower, India - Maharashtra - Worli Mumbai
Req ID : 388729
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 29th February, 2024
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