GSK - Regulatory Specialist - MSR Coordination (1-3 yrs)
- Liaise with MSR suppliers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
- Prepare the Market Specific Requirements package for regulatory submissions.
- Ensure appropriate archival of MSR data package.
- Organise dispatch of MSRs.
- Update tracking systems (e.g., OPAL) with dispatch dates and D-numbers as defined by process documents.
- Escalates changes through the relevant process.
- Minimum Level of Experience:
- Minimum 1 - 3 years of relevant experience
- Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions.
- 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 organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
- Ability to build effective working relationships and work in a matrix environment effectively
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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