Biological Sciences Regulatory Specialist Job Opening at GSK, Apply Online
GSK is a leading global pharmaceutical company committed to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong emphasis on scientific innovation, GSK develops and distributes a wide range of prescription medicines, vaccines, and consumer healthcare products.
Job Title: Regulatory Specialist III MSR Co-ordinator
Location: Bengaluru, India
Employment Type: Full Time
Site Name: Bengaluru Luxor North Tower
Posted Date: Nov 20, 2023
The Regulatory Specialist III MSR Co-ordinator at GSK will provide support for GRA regulatory delivery activities of assigned projects. Key responsibilities include executing dossier strategies, managing project assignments, completing data assessments, and communicating with the line manager to identify business impact issues.
- Execute agreed dossier strategy related to MSR packages with minimal input from the manager.
- Liaise with MSR suppliers to obtain documentation in a timely manner.
- Manage multiple project assignments supporting Variations, Product Expansion dossiers, Renewals, and regional projects simultaneously.
- Complete data assessment to ensure MSR package is fit for purpose and identify risks associated with submission data and MSR packages.
- Communicate with the line manager to identify issues with business impact.
- Review work of peers and identify improvement opportunities for Regulatory processes, policies, and systems.
- Develop an understanding of regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical and vaccine products.
- Understand the internal/external Regulatory environment.
- Build an organizational network within GSK.
- Communicate across GSK regarding projects and new requirements impacting MSR deliverables with minimal input from the manager.
Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment or Chemistry, pharmacy, or other related science or technical bachelor’s degree.
- Minimum 1-5 years of relevant experience
- Demonstrated ability to proactively manage workload, timelines, and identify priorities.
- Proven ability to work on multiple projects simultaneously.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global/EMAP Regulatory submission experience – Knowledge of regulatory agency guidelines.
- Excellent organizational skills, attention to detail, and commitment to deliver high-quality output.
- Excellent written and verbal communication skills and ability to present information clearly and concisely.
- Ability to interpret and advise on guidelines and requirements on a global basis.
- Ability to build effective working relationships and work in a matrix environment effectively.
- Ability to think flexibly to meet constantly shifting priorities and timelines.
Keywords: Biological Sciences Regulatory Specialist, GSK, Bengaluru, India, Full Time, Regulatory Affairs, Drug Development, Pharmaceutical Industry. Biological Sciences Regulatory Specialist Job Opening at GSK, Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook