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GlaxoSmithKline Pharmaceuticals
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61 GlaxoSmithKline Pharmaceuticals Jobs
Submission Manager
10-15 years
Bangalore / Bengaluru
1 vacancy
Submission Manager
GlaxoSmithKline Pharmaceuticals
posted 16hr ago
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Flexible timing
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Job Description
Years of experience 10 - 15 Years.
Education - Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment Location - Bangalore.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
- 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, label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc)
- May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
- May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
- 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
- May be required to lead or participate to process improvement initiatives
- May be required to take on additional Project Management responsibilities if identified as Single Point of Contact (SPOC) for the GRL
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
- Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools
- Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams
- Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
- Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc.
Employment Type: Full Time, Permanent
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