GSK Bengaluru Regulatory Affairs Job opportunity is out for the Regulatory associate manager-I/ II / III-CTA/IND development delivery. Eligible candidates may apply Directly by using Apply now.
GSK is a big Pharmaceutical company that wants to use science, tech, and skilled people to fight diseases together. We want to make lots of people healthier and also make good profits for our investors. We want our team to do well and grow. We’re not just about treating diseases but also stopping them. Our goal is to make 2.5 billion people healthier in the next 10 years all over the world.
GSK Bengaluru Regulatory Affairs Job Overview:
Company Name | GSK |
Req ID | 388729 |
Post | Regulatory associate manager-I/ II / III-CTA/IND development delivery |
Experience | 5 years of relevant experience |
Industry Type | Pharma / Healthcare/ Clinical research |
End Date | 29th February, 2024 |
Location | Bengaluru Luxor North Tower, India – Maharashtra – Worli Mumbai |
Other Regulatory Job | Check here |
Apply Online | Apply Here |
Key Responsibilities
The key responsibilities for the GSK Bengaluru Regulatory Affairs Job are as follows:
- Possess a broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Demonstrate a good understanding of the Clinical Trial Directive, DIA TMF Reference Model, and CTA/IND submission requirements for various countries and submission types.
- Take responsibility for the coordination, development, and refinement of the CTA/IND lifecycle strategy. Ensure timely content and delivery tailored to each regulatory agency while adhering to GSK policy and procedures.
- Report to the CTA Team Manager for overall work plans and provide accountability to individual GRLs/TGs for study submission planning and delivery status.
- Be accountable for agreed tasks and projects.
- Independently communicate with a range of internal GSK staff to support the achievement of assigned goals.
- Ensure the quality of both personal work and the submission team’s work, delivering within agreed timeframes and complying with GSK systems and record-keeping standards.
- Provide input to internal processes and written standards.
- Be flexible to work in order to meet constantly shifting priorities and timelines.
- May offer support to other activities within the CTA/IND and/or Content Delivery Team.
Note: GlaxoSmithKline does not charge any fee for the recruitment process. Please refrain from making payments to any individuals or entities in connection with the recruitment process at any worldwide location of GlaxoSmithKline (or GSK) group companies. It is essential to note that even if they claim that the money is refundable, such payments should not be made.