Regulatory Specialist
2 weeks ago
About the job
Site Name: Bengaluru Luxor North Tower
Key Responsibilities :
- Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices
- May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations/renewals/variations, label harmonization, periodic benefit risk evaluation reports (PBRER) submissions etc)
- May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets
Job Related Experience :
- Awareness of the pharmaceutical industry, drug development environment, and RD processes and objectives.
- Awareness of Regulatory Affairs responsibilities from pre-IND through Phases I-IV
- Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Ability to interpret regulations
Other Job-Related Skills:
- Good written and verbal communication skills and ability to present information in a clear and concise manner
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
- Ability to work flexibility in large teams
Please use the below link for job application and quicker response.
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