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Regulatory Specialist require at GSK Rx India

 

Clinical courses

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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