GSK Regulatory Specialist Job for Biological Sciences
Position: Regulatory Specialist MSR Coordination – Senior-1
Location: Bangalore, India
Job Description
Site Name: India – Karnataka – Bengaluru
Posted Date: Jan 17, 2024
Req ID: 387480
Job Purpose:
- Provides support for GRA regulatory delivery activities (e.g., Variations, Product Expansion dossiers, Renewals and regional projects) of assigned projects with management input.
- Supports Global Regulatory by authoring and coordinating appropriate MSR packages for global regulatory submissions with appropriate guidance from supervisor, as necessary.
- May have training responsibilities for new staff on established departmental processes.
Key Responsibilities
- Executes agreed dossier strategy related to MSR packages with minimal input from manager
- Liaises with MSR suppliers & customers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner
- Manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals, and regional projects simultaneously
- Completes data assessment to ensure MSR package is fit for purpose and identifies associated risks
- Reviews work of peers and identifies improvement opportunities for Regulatory processes
- Develops understanding of regulations, guidelines, and procedures relating to pharmaceutical and vaccines products
- Builds effective working relationships and communicates across GSK regarding projects and new requirements
Educational Background
- Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
- Masters degree or higher in biological or healthcare science is appropriate for the role
Job-Related Experience
- Minimum 1 – 6 years of relevant experience
- Demonstrated ability to proactively manage workload and identify priorities
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes
- Knowledge of regulatory agency guidelines
- Excellent organizational, written, and verbal communication skills
- Ability to build effective working relationships and work in a matrix environment effectively
Apply Now
To apply for the Regulatory Specialist position at GSK, please follow the link below:
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