GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. With a focus on innovation and inclusion, GSK is committed to improving the health and well-being of people around the world. The company fosters a diverse and inclusive work environment, encouraging employees to bring their authentic selves to work.
Job Description
GSK is seeking a Regulatory Specialist III, Country Labelling to join its team in Bengaluru. This role is critical in ensuring compliance with regulatory authority labelling requirements and maintaining high standards in labelling documentation.
Key Responsibilities:
- Author and Compile Labelling Documents:
- Prepare Regional/Country Product Information (PI) in line with regulatory authority requirements and GSK standards.
- Create market-specific supporting documentation for labelling submissions.
- Quality Assurance:
- Conduct quality and consistency checks on labelling document content.
- Manage labelling documentation and data in regulatory systems efficiently.
- Collaboration and Communication:
- Provide advice on labelling requirements and processes to global and local GRA teams.
- Communicate effectively with GSK staff, including GRA, Global Safety and Medical, and Local Operating Companies.
- Liaise with Regulatory Agencies and third parties as needed.
- Additional Responsibilities:
- Support other regulatory functions and contribute to labelling process improvements.
- Perform translation of labelling text into identified languages (if required).
- Develop expertise in country/regional labelling content and processes.
Basic Qualifications:
- Education: Bachelor’s degree in Science or Life Sciences.
- Experience: 2-6 years in regulatory affairs, specifically in country labelling.
- Skills: Strong knowledge of regulatory labelling requirements and processes.
Good-to-Have Skills:
- Experience in regulatory document management, particularly with Product Information/Labelling Documents.
- Familiarity with regulatory systems and communication tools.
- Knowledge of EU (including Linguistic Review) and US label content and requirements.
- Experience with XML Labelling.
- Prior experience in managing local and global labelling documents and submissions.
- Experience communicating with regulatory agencies.
Why Join GSK?
- Innovative Environment: Work at the forefront of science and technology to combat diseases.
- Inclusive Culture: GSK is committed to creating a workplace where everyone feels valued and supported.
- Career Growth: Opportunities to develop expertise and grow within a global organization.
- Work-Life Balance: Flexible working arrangements to support your personal and professional life.
How to Apply
If you meet the qualifications and are excited about this opportunity, apply before the deadline on March 14, 2025.
Advertisement
