Regulatory Affairs Jobs at GSK | Chemistry Candidates Apply
Are you looking for Regulatory Affairs Jobs in Bengaluru that can take your career to the next level? Here’s an exciting opportunity at GSK for professionals seeking strong growth in GSK Careers and BSc Chemistry Jobs. If you have experience in CMC regulatory activities and want to work with a global pharmaceutical leader, this Regulatory Specialist role could be the perfect fit for you.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. The company aims to positively impact the health of 2.5 billion people by the end of the decade as a successful, growing organization where people can thrive. GSK focuses on innovation in specialty medicines and vaccines across four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. Through strong GSK Careers opportunities and impactful Regulatory Affairs Jobs, professionals contribute to improving global health while building rewarding careers in the pharmaceutical industry.
Regulatory Specialist – Regulatory Affairs Jobs
- Location: Bengaluru, India
- Category: Regulatory
- Job ID: 435916
Job Description – GSK Careers
- Site Name: Bengaluru Luxor North Tower
- Job Title: Regulatory Specialist
Job Purpose:
In this role under Regulatory Affairs Jobs at GSK, you will play a key part in delivering high-quality CMC (Chemistry, Manufacturing and Controls) Annual Reports and associated regulatory activities for GSK’s global Pharma (Rx) and Vaccine (Vx) portfolio. You will work closely across GSK’s global regulatory network to prepare Annual Reports for NDAs (New Drug Applications), BLAs (Biologics License Applications), DMFs (Drug Master Files), Canadian Annual Notifications, as well as Brazil and China CMC Annual Reports.
You will prepare technical documentation, ensure compliance with worldwide post-approval requirements, and contribute your regulatory expertise to support the continued quality, safety, and availability of GSK products.
This opportunity within GSK Careers is ideal for candidates exploring BSc Chemistry Jobs and looking to strengthen their CMC knowledge while improving processes and digital capability within the organization.
Key Responsibilities – Regulatory Affairs Jobs
- Take responsibility for the planning, preparation, technical review, and delivery of CMC Annual Reports for NDAs, BLAs, DMFs, Canadian Annual Notifications, and Brazil/China Annual Reports for GSK’s established Pharma and Vaccine product portfolio.
- Actively build relationships and maintain strong collaboration with internal and external stakeholders, including LOCs (Local Operating Companies), Product Owners, manufacturing sites, Submission Leads and Teams, and others.
- Contribute to the creation, improvement, and implementation of working practices aimed at simplifying processes and enhancing quality.
- Monitor regulatory intelligence and proactively act on changes to global regulatory requirements.
- Manage multiple submissions and projects simultaneously while maintaining accuracy, completeness, and timeliness.
- Identify opportunities for increased efficiency and drive improvements within the Annual Reporting processes.
- Support the development of digital fluency within the team and broader organization.
- Provide training or mentoring as needed.
Basic Qualifications – BSc Chemistry Jobs & Regulatory Careers
- Bachelor’s degree in Life Sciences, Chemistry, Health Sciences, Pharmacy, or a related discipline.
- Minimum 2 years’ experience performing CMC regulatory activities.
- Experience in the pharmaceutical industry and regulatory affairs.
- Experience or knowledge of worldwide CMC post-approval regulatory requirements.
- Fluent English, both written and spoken.
Preferred Qualifications
- Experience with CTD/eCTD (Common Technical Document/electronic Common Technical Document) documentation and global regulatory submissions/markets.
- Experience or understanding of drug development, manufacturing, or supply processes.
Attributes
- Organizational and analytical skills.
- Attention to detail with a focus on accuracy and completeness.
- Interpersonal skills and communication skills to effectively collaborate in a diverse global team environment and build relationships across a large organization.
