Manager-RRDM

Site Name: India - Karnataka - Bangalore R&D
Posted Date: Jan 13 2020
Minimum Level of Job Experience Required:

  • 7+ years' relevant experience within a regulated or quality-critical environment (e.g. Pharmaceutical Industry Regulatory) of which 2+ years of experience in people management or project management
  • Understanding of regulatory procedures and their applicability within Regulatory Information Managements Systems (RIMS).
  • Attention to detail, excellent organization and time management skills.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines and to independently provide solutions to issues.
  • Well-developed understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
  • Well-developed understanding of RRDM (Records and Registration Data Management) systems.
  • Strong interpersonal skills, global collaboration and contribution

Key Responsibilities:

The information managed is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work, their direct reports and for the support of the large number of other users across GSK.
  • Manage HR aspects for a team of direct reports including recruitment
  • Manage workload within assigned team and work with other managers within functional area to address resource challenges
  • Provide peer review and quality check support as requested and able
  • Serve as point of escalation for team members
  • Maintain a workload in area of responsibility
  • Participate in quality or continuous process improvement activities related to area of responsibility or as requested
  • Maintain appropriate organizational networks
  • Recognizes matters that affect corporate or agency policies and escalates issues with high business impact or risk.
  • Independently and confidently executes agreed assignments strategy
  • Independently manages multiple project assignments in the area of responsibility simultaneously; assignments will range in complexity but more complex work is expected
  • Independently completes data assessment/data maintenance tasks/complex submission packages to ensure output is fit for purpose.
  • Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products/registration data management/submission format to expedite submission, review and approval of global applications.
  • Advise and assist authors with more complex or non-routine assignment.

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

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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