GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Post : Regulatory Specialist - MSR Coordination
• Provides support for GRA regulatory delivery activities (e.g., Variations, Product Expansion dossiers, Renewals and regional projects) of assigned projects with management input.
• Supports Global Regulatory by authoring and coordinating appropriate MSR packages for global regulatory submissions with appropriate guidance from supervisor, as necessary.
• May have training responsibilities for new staff on established departmental processes.
Key Responsibilities :
1. With minimal input from manager, executes agreed dossier strategy related to MSR packages
2. Liaise with MSR suppliers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
3. With minimal input from manager, manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals and regional projects simultaneously; MSR packages/documents will range in complexity
4. With minimal input from manager, completes data assessment to ensure MSR package is fit for purpose, identifies risks associated with submission data and MSR packages.
5. Communicates with line manager to identify issues that have business impact.
6. May have responsibilities for reviewing work of peers and may identify improvement opportunities for Regulatory processes, policies and systems.
7. Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products,
8. Understands internal/external Regulatory environment.
9. Actively builds an organizational network.
10. Communicates across GSK, with minimal input from manager regarding projects and new requirements impacting MSR deliverables
• Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Chemistry, pharmacy or other related science or technical bachelors degree.
• Minimum 1- 5 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.
Experience : 1- 5 years
Qualification : B.Pharm / B.Sc
Location : Bengaluru
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 10th August, 2023
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