Regulatory Specialist - Submission Coordinator

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.

https://lifelancer.com/jobs/view/26f8294d83630c1e668e59f77d8f01dd