GSK India Ltd looking for Regulatory Specialist

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, Variations – Senior

Job description
• With minimal input from manager, executes agreed dossier strategy
• With minimal input from manager, manages multiple project assignments (e.g., Variations

Candidate Profile
• Minimum 5-7 years of relevant experience
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
• 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, reflecting recent GSK experience
• Ability to build effective working relationships and work in a matrix environment effectively.
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Additional Information
Experience : 5-7 years
Location :
Worli Mumbai, Bangalore
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Variations
Req ID : 275571
End Date : 20th january, 2021

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