GSK - Specialist/Senior - Regulatory Policy & Intelligence (5-8 yrs)
Job description :
Site Name: India - Maharashtra - Worli Mumbai, Bengaluru Luxor North Tower
Reporting into Global Regulatory Centre in India, with a dotted reporting line into the Global Head Regulatory Intelligence & Systems, the job holder (JH) is accountable for coordinating and tracking the flow of information into the relevant Regulatory Intelligence Database (RID) and providing oversight in terms of training and communication.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of the following:
In performing this role, the job holder:
- Will verify and timely enter the correct information into the intelligence database
- Lead training efforts related to the internal intelligence database
- Support timely communication of major changes to requirements to appropriate regulatory staff
- Participate, as needed, in the activities related to the redevelopment of the IT platform where intelligence is located
- The JH will need to interact closely with LOC (local operating company) colleagues globally, to support the flow of regulatory intelligence on submission requirements into GSK's central intelligence database.
- The JH plays a pivotal role in the process by ensuring intelligence items are fully characterized and tracked providing visibility to the LOC of where in the process their information is. They also support relevant staff in monitoring the progress of items, chasing up outstanding responses and facilitating smooth running of the end-to-end process.
- The JH will be responsible for supporting and delivering training on a global basis to LOC, Regional and Central staff.
- The JH will also act as key interactor with the IT system support for the RID (e.g. for issue resolutions)
- The JH will also be required to support activities to capture, and process regulatory intelligence items using relevant databases (e.g. Cortellis). Therefore, coordinate with LOCs to validate the relevance of these items for GSK will be required
- The JH may also be involved to support the wider team communication activities
- JH will Plan, communicate and execute activities with minimal input from manager
- Other tasks e.g. collecting responses, assisting in data collection, analysis and reporting to support position development
Minimum Qualification :
- We are looking for professionals with these required skills to achieve our goals:
- Minimum 5 years of experience with Global/ EM GCI /EU Regulatory submission experience - Knowledge of regulatory agency guidelines
- Knowledge of regulatory requirement data capture systems or similar databases
- Awareness of regulatory agency guidelines and expectations for submissions, particularly in the Emerging Market
- Working knowledge of electronic databases and basic knowledge of IT systems
- Basic understanding of the GSK portfolio
Why GSK? :
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.
Note - For your candidature to be considered on this job, you need to apply necessarily on the redirected career page of the company as well.