Manager - Regulatory Submissions Assembly

    • Bangalore, India

Site Name: India - Karnataka - Bangalore
Posted Date: Aug 29 2019

Key Responsibilities

  • Coordinate, engage & Lead delivery of complex submission packages to agreed schedule and technical specification with stakeholders across GRA, GRPD & Local Operating Companies.
  • Check compliance of others' work with requirements and standards as per the market specifications
  • Advise and assist customers with more complex or non-routine issues coming out of Assembly work on regular basis
  • Support & Lead in setting up of process maps/Guides/QRGs for markets transitioning to implement Assembly process
  • Lead the creation and implementation of working practices and procedures aimed at simplifying processes and maintaining quality in Assembly team for various markets.
  • Identify risks & Lead in preparing action plans in mitigating the identified risks & issues
  • Ensure proper Management oversight procedures are in place (Eg: QC process for quality conformance, check lists etc.) to deliver high quality dossiers to various customers
  • Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with Assembly team and handle any other work coming out of them
  • Supervise and support the work of Submissions Assembly Associates and Specialists
  • Manage HR aspects for a team of direct reports including recruitment
  • Generate appropriate metrics and key performance indicators for the team, and use metrics to develop and enhance capability in the CoE

Job-Related Experience
  • 8-10 years of experience in Regulatory Affairs or related responsibilities
  • Managed an operational/production team of more than 5 people that successfully delivered outputs to time and quality over a sustained period
  • Worked within a global organization across different geographical locations
  • Successfully performed within a regulated or quality-critical environment
  • Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations for both Investigational and Licensed Products
  • Successful and sustained delivery of a significant number of submission packages including a broad range of submission types across eCTD Markets.
  • Team Handling experience is Mandatory.

Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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