Regulatory Specialist require at GSK Rx India
GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : Regulatory Specialist
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 submission requirements for multiple countries/submission types
• Responsible for: coordination, development, refinement of the CTA 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 in order to meet constant shifting priorities and timelines
• May provide support to other activities within the CTA and/or Content Delivery Team.
Candidate Profile
• Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
• 3-5 years of relevant experience
• Role requires a general understanding of CTA submission requirements for multiple countries/ submission types and an ability to work in a matrix environment.
• Knowledge of practical implementation of the European Clinical Trial Directive.
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• A good understanding of Clinical Trial Directive and CTA submission requirements for multiple countries/submission types
• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to interpret and advise on guidelines and requirements on a global basis
• Ability to build effective working relationships and work in a matrix environment effectively
• Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
• Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Additional Information
Experience : 3-5 years
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory
Req ID : 276385
End Date : 30th April, 2021
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