GSK Chemistry & Pharmacy Job


GSK Chemistry & Pharmacy Job - Regulatory Specialist Post

GSK Chemistry & Pharmacy Job – Regulatory Specialist Post

GSK Hiring chemistry and pharmacy job opening 2022. Chemistry job opening 2022. Pharmacy job opening 2022, Regulatory Specialist job opening 2022. BSc Chemistry and B Pharmacy job opening 2022, GSK job opening 2022; check out all the details on the same below:

Job Title: Regulatory Specialist CTA/IND Development Delivery

Location: Bengaluru, India

Id: 343220

Eligbility Criteria:

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

Job-Related Experience

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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