GSK Regulatory Specialist Job For Biological Sciences
GSK Regulatory Specialist Job For Biological Sciences. GlaxoSmithKline Regulatory Specialist, CMC Variations job opportunities. Regulatory Specialist, CTA Senior Careers at GSK. GlaxoSmithKline GSK Bengaluru vacancies for Regulatory Specialist. Check out all of the details below:
Name of the Position: Regulatory Specialist, CTA Senior
Locations: Bangalore, India
Req ID: 276385
Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to aid 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 certainly work with the Governance, Compliance, and also 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 with 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 also 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 also projects.
- Ensure independent communication, with a range of internal GSK staff, in supporting the achievement of the assigned goals.
- Guarantee 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 also written standards.
- To work flexibly in order to meet constantly shifting priorities and also timelines
- May provide support to various other activities within the CTA and/or Content Delivery Team.
We are seeking an experienced 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 pertinent experience
- The 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 also R&D processes and objectives.
- A good understanding of Clinical Trial Directive and CTA submission requirements for multiple countries/submission types
- Outstanding organisational skills, attention to detail and commitment to deliver high-quality output, even under pressures sometimes demanded by regulatory deadlines
- Outstanding written and also verbal communication skills and also capability to present info in a clear and concise manner
- Ability to interpret and also advise on standards and requirements on a global basis
- Capability to build effective working relationships and also work in a matrix environment effectively
- Capability 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 greater than one way of achieving a successful outcome.
- Capability to think flexibly in order to meet constantly shifting priorities and timelines.
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