Regulatory Specialist SDE Investigational Job at GSK India
The Regulatory Specialist, SDE – Investigational role at GSK offers an exciting opportunity to support global clinical trial submissions and regulatory operations. Based in India, this Regulatory Affairs Job role enables professionals to work at the intersection of science, compliance, and innovation while contributing to life-changing medicines across multiple geographies. Graduates seeking B pharma jobs, and wanting to start their careers with GSK Careers can apply now.
Regulatory Affairs Job Details
- Job Title: Regulatory Specialist, SDE – Investigational
- Location: Bengaluru, India; Worli, Mumbai, India
About the Company
GSK is a global biopharma company uniting science, technology, and talent to get ahead of disease together. With a strong focus on vaccines and specialty medicines, GSK aims to positively impact the health of 2.5 billion people by the end of the decade. The company fosters a culture that is ambitious for patients, accountable for impact, and committed to doing the right thing, while enabling employees to thrive and grow. This Regulatory Affairs Job role plays a significant role in the company.
Educational Requirements
-
Bachelor’s degree in pharmacy
Key Responsibilities
- Contributing to preparation of Clinical Trial Application (CTA) packages for EU and Non-EU regions is required for this Regulatory Affairs Job role.
- Support submission packages for CTA amendments, End of Trial Notifications, and Study Summary submissions
- Assist in planning and compilation of DSURs, INDs, and IND amendments
- Ensure compliance with Global Regulatory Affairs SOPs and regulatory system processes
- Collaborate with cross-functional teams to meet submission timelines
- Maintain awareness of emerging investigational regulatory requirements
- Communicate risks and issues to senior stakeholders
Skills Required for Regulatory Affairs Job Role
- Knowledge of global pharmaceutical regulatory procedures
- Understanding of regulatory submission requirements and standards
- Ability to coordinate regulatory submission activities
- Strong collaboration skills in matrix and global teams
- Attention to detail and ability to meet project timelines
- Familiarity with regulatory systems and documentation processes
Why This Regulatory Affairs Job Role?
- Opportunity to work on global investigational submissions across multiple regions
- Hands-on exposure to clinical development and regulatory operations
- Strong focus on learning, career development, and continuous improvement
- Purpose-driven role contributing to global health impact
- Inclusive and collaborative work culture at a leading biopharma company
- Graduates seeking B pharma jobs, and wanting to start their careers with GSK Careers can apply now.
