Regulatory Associate Manager – Global Labelling at GSK
Location: Bengaluru, India
Position: Regulatory Associate Manager – Global Labelling
Organization: GSK
Experience Required: 7+ years
Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacology, or equivalent
Job Overview
As a Regulatory Associate Manager at GSK, you will manage global and local product information, ensuring compliance with standards and regulations. You will handle product labelling, submission processes, and process improvements.
Key Responsibilities
Global Datasheet and Product Information Maintenance
- Maintain Global Datasheet (GDS) with functional experts.
- Oversee EU PI, International Product Information, and Medical Device product labels.
- Ensure compliance with global PI and manage country-specific labelling.
Product Information Management
- Coordinate product information with third-party partners.
- Lead discussions on GDS and centrally managed PIs.
- Author and coordinate submission packages.
Submission and Documentation
- Write meeting minutes and support Local Operating Companies (LOC) in implementing Global PI text.
- Address labelling questions from regulatory agencies.
Process Improvement and Compliance
- Demonstrate expertise in GSK Global Labelling processes.
- Identify and implement improvements in labelling processes.
Reporting and Collaboration
- Contribute to periodic aggregate reports.
- Participate in Regulatory Matrix Team (RMT) and Safety Review Team (SRT).
- Represent Global Labelling in internal audits and external events.
Training and Development
- Train and coach others in global labelling processes.
Qualifications
Education:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacology, or equivalent.
Experience:
- 7+ years in the pharmaceutical industry or regulatory affairs.
- Experience in labelling or regulatory affairs preferred.
Why GSK?
Join GSK to work in a dynamic environment where you can contribute to global health advancements and professional growth.
How to Apply:
Apply now to be part of GSK’s mission to advance science and technology. Click here to apply.
