GSK Biological Sciences Job – Regulatory Specialist Vacancy
GSK Biological Sciences Job – Regulatory Specialist Vacancy. GlaxoSmithKline Regulatory Specialist CTA job opportunities. Careers at GSK. GlaxoSmithKline GSK Bengaluru vacancies for Regulatory Specialist CTA. Check out all of the details below –
Name of the Position – Regulatory Specialist CTA/IND Development Delivery
Locations – Bangalore, India
Categories – Regulatory
Req ID – 343220
Job description
- Coordination of CTA/IND submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures
- Accountable to the functional CTA/IND Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project.
- Accountability for agreed tasks and projects.
- Ensure independent communication, with a range of internal GSK staff, in support achievement of the assigned goals.
- Ensure compliance with GSK CTA/IND process through timely action and completion of records in internal GSK systems
- Ensure quality of own work to agreed timeframes, including compliance with GSK systems and record keeping.
Knowledge/ Education / Previous Experience Required*
A. Educational Background
1. Minimum Level of Education*
Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
Area of Specialisation*
Chemistry, pharmacy or other related science or regulatory affairs
Why is this Level of Education Required?
Working in complex environment within a scientific organization
B. Job-Related Experience
Minimum Level of Job-Related Experience required
- 2-3 years of relevant experience
Why is this Level of Experience Required?
Role requires a general understanding of CTA/IND submission requirements for multiple countries/ submission types and an ability to work in a matrix environment.
C. Other Job-Related Skills/Background
- Knowledge of practical implementation of the European Clinical Trial Directive.
- Knowledge and experience of filing artefacts per the DIA Trial Master File Reference Model.
- Knowledge of clinical trial application process and review for countries outside Europe would be an advantage.
- Understanding of the use and importance of internal tracking to ensure compliance with reporting and other requirements for each study protocol.
- Pays attention to detail; is aware of the importance of accuracy and the need for compliance with internal and external policy and regulations.
- Sound interpersonal and communication skills to ensure sound level of engagement of others
- An ability to manage multiple tasks in parallel and organize time and actions within submission or project timeframes
- Able to work effectively in, and promote, sound team working across organizational boundaries
- Works co-operatively with others, individually or in teams, in order to achieve project or product goals.
- Takes time to reflect on own performance and learn from experience to improve overall performance and input to process improvements to benefit other projects.
- Ability to work in multiple IT systems (filing, tracking & repositories)
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