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06/04 Kimberlee
HR Manager at GSK

Views:36 Applications:7 Rec. Actions:Recruiter Actions:0

GSK - Regulatory Specialist/CTA Senior (3-5 yrs)

Bangalore/Karnataka Job Code: 910753

- Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this Regulatory Affairs Operations role could be an exciting opportunity to explore.


- As a Regulatory Affairs Operations Staff, you will work with the Governance, Compliance, and the Systems team within Global Labelling to ensure that labelling updates in Online Product Authorisation and Lifecycle (OPAL) are monitored and managed in compliance with GSK procedures.


This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:


- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.


- A good understanding of Clinical Trial Directive, DIA TMF Reference Model and CTA submission requirements for multiple countries/submission types


- Responsible for: coordination, development, refinement of the CTA lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures.


- Accountable to the CTA Team Manager for overall work plans, accountable to individual GRLs/TGs for study submission planning & delivery status.


- Accountability for agreed tasks and projects.


- Ensure independent communication, with a range of internal GSK staff, in supporting achievement of the assigned goals.


- Ensure quality of both own and submission team's work, delivering to agreed timeframes, including compliance with GSK systems and record keeping.


- Provide input to internal processes and written standards.


- To work flexibly in order to meet constant shifting priorities and timelines


- May provide support to other activities within the CTA and/or Content Delivery Team.


- We are looking for an experience individual and if you have these skills, we would like to speak to you. Bachelor's degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment


- 3-5 years of relevant experience


- Role requires a general understanding of CTA submission requirements for multiple countries/ submission types and an ability to work in a matrix environment.


- Knowledge of practical implementation of the European Clinical Trial Directive.


- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.


- A good understanding of Clinical Trial Directive and CTA submission requirements for multiple countries/submission types


- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines


- Excellent written and verbal communication skills and ability to present information in a clear and concise manner


- Ability to interpret and advise on guidelines and requirements on a global basis


- Ability to build effective working relationships and work in a matrix environment effectively


- Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.


- Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.


- Ability to think flexibly in order to meet constantly shifting priorities and timelines.


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. 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.


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.

Women-friendly workplace:

Maternity and Paternity Benefits

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