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Are you looking to grow your career in Regulatory Affairs with a leading global biopharma company? GlaxoSmithKline (GSK) is hiring a Regulatory Specialist Submission Specialist in Bengaluru, India. This role offers an exciting opportunity to work on drug development, regulatory submissions, and lifecycle management in a collaborative and innovative environment.
At GSK, youโll play a key role in ensuring compliance with global health authorities, supporting drug approvals, and helping millions of patients worldwide.
๐ Key Responsibilities
As a Regulatory Specialist Submission Specialist, you will:
- Deliver marketing application submissions, pre-approval documents, and lifecycle maintenance submissions in compliance with global regulations.
- Lead submission teams for approved products including renewals, site registrations, variations, and PBRERs.
- Guide project teams on submission processes, formats, and regulatory requirements for key global markets.
- Collaborate across R&D, regulatory teams, and global stakeholders to ensure timely approvals.
- Interpret and apply regulatory guidelines to support product development and commercialization.
๐ Qualifications
Basic Qualifications:
- Awareness of the pharmaceutical industry, drug development, and R&D processes.
- Knowledge of Regulatory Affairs from pre-IND through Phases IโIV.
- Strong organizational skills with attention to detail.
- Ability to interact effectively across teams and adapt to shifting priorities.
Preferred Qualifications:
- Bachelorโs degree (or higher) in biological, healthcare, or scientific discipline.
- Excellent written and verbal communication skills.
- Commitment to delivering high-quality regulatory documentation under strict timelines.
๐ Why Join GSK?
At GSK, you will be part of a mission-driven organization that:
- Focuses on four therapeutic areas โ Respiratory, Immunology, Oncology, HIV & Infectious Diseases.
- Aims to positively impact the health of 2.5 billion people by 2030.
- Provides a collaborative culture where people can thrive, innovate, and grow.
- Offers opportunities to contribute to global healthcare transformation.
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