GSK Chemistry & Pharmacy Job – Regulatory Specialist Post
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Job Title: Regulatory Specialist CTA/IND Development Delivery
Location: Bengaluru, India
List any academic or practical education that must be obtained to be qualified to perform this role.
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
Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.
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.
Other Job-Related Skills/Background
List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
- 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)
Key Responsibilities (10 bullet points maximum)
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
- 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.
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