GlaxoSmithKline (GSK), a leading global biopharma company, is inviting applications for the role of Regulatory Specialist – Submission Coordination. Based in Bengaluru Luxor North Tower, this position offers the opportunity to work closely with global submission teams and regulatory contacts, delivering end-to-end submissions in compliance with global health authority regulations and GSK SOPs. With only 2 days left to apply (deadline: August 14, 2025), now is the perfect time to advance your Regulatory Affairs career.
Key Responsibilities
As a Regulatory Specialist, you will:
- Deliver marketing applications and lifecycle maintenance submissions (renewals, site submissions, variations) within agreed timelines.
- Coordinate MSR for multiple submission types, independently executing agreed dossier strategies.
- Support scenario planning when multiple regulatory strategies are under consideration.
- Identify and escalate submission delivery risks impacting business operations.
- Apply regulatory guidelines to expedite submission processes.
- Participate in process improvement initiatives.
- Support submission teams for renewals, site registrations, PBRER submissions, and more.
- Mentor and train junior team members as needed.
Qualifications
Required Skills & Experience:
- Degree in Biological Sciences, Healthcare, or a related scientific discipline, or extensive Regulatory Affairs experience.
- Understanding of pharmaceutical industry regulations and R&D processes.
- Ability to interpret and apply regulatory guidelines effectively.
- Strong communication skills, both written and verbal.
- Organizational excellence with attention to detail.
- Risk identification and mitigation skills.
- Ability to lead multidisciplinary meetings and facilitate discussions.
Why Join GSK?
GSK is committed to uniting science, technology, and talent to advance global health. As part of the team, you will:
- Contribute to life-saving medicines and vaccines.
- Work in a diverse, inclusive, and growth-oriented environment.
- Gain global exposure in regulatory submissions.
- Receive competitive salary and benefits.
Application Process
- Location: Bengaluru, Karnataka, India
- Deadline: August 14, 2025
