GSK - Manager - RRDM - Pharmaceuticals & Vaccines (7-11 yrs)
- Ensures that GSK product (Pharmaceuticals and Vaccines) registration information and regulatory records are maintained to a standard appropriate to support critical regulated processes including Pharmacovigilance and GMP-compliant product supply.
- This data also support the efficient operational management of the Regulatory function, worldwide. The role provides operational support to Regulatory Information Management Systems (RIMS) end-users.
- In this role, manager has managerial responsibility for a number of direct reports as well as accountability for completion of assigned work in their regulatory area. Manager is the point of escalation for resource or quality considerations.
- 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.
- We are looking for professionals with these required skills to achieve our goals:
- 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 systems.
- Strong interpersonal skills, global collaboration and contribution
Our values and expectations are 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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