Company: GSK
Experience: 2 – 6 Years
Location: Bangalore
Salary: Rs. 28,000 – Rs. 70,000
Education: M.Sc / B.Pharm / M.Pharm
About GSK:
GSK is a focused biopharma company with strong momentum and big ambitions, combining science, technology, and talent to get ahead of diseases.
Position Overview:
As a Regulatory Specialist MSR Coordination at GSK Bangalore, you will play a crucial role in executing dossier strategies related to Market-Specific Requirements (MSR) packages with minimal input from the manager. Your responsibilities will include liaising with MSR suppliers and customers, managing multiple projects simultaneously, assessing data for MSR package suitability, communicating issues and improvements, and developing an understanding of regulations and policies related to the registration and manufacturing of pharmaceutical and vaccine products.
Key Responsibilities:
- Execute agreed dossier strategy related to MSR packages.
- Liaise with MSR suppliers & customers to obtain documentation.
- Manage multiple project assignments supporting variations, expansions, and renewals.
- Complete data assessment to ensure MSR package compliance.
- Communicate with line manager to identify issues and improvements.
- Review work of peers and identify improvement opportunities.
- Develop an understanding of regulations, guidelines, and procedures.
- Actively build an organizational network.
- Communicate across GSK regarding projects and new requirements.
Candidate Profile:
To excel in this role, you should have a Bachelor’s degree in Biological or Healthcare Science or relevant experience within regulatory affairs in the drug development environment. You must possess a minimum of 2-6 years of relevant experience, the ability to proactively manage workload and timelines, proven ability to work on multiple projects simultaneously, a broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives, global/EMAP regulatory submission experience, excellent organizational skills, attention to detail, commitment to deliver high-quality output, even under pressure, excellent written and verbal communication skills, ability to interpret and advise on guidelines and requirements on a global basis, ability to build effective working relationships, and work in a matrix environment effectively, ability to think flexibly to meet constantly shifting priorities and timelines.