Job Description

Job Purpose :

• 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 :

With minimal input from manager, executes agreed dossier strategy related to MSR packages Liaise with MSR suppliers & customers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner. 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 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. Communicates with line manager to identify issues that have business impact. May have responsibilities for reviewing work of peers and may identify improvement opportunities for Regulatory processes, policies and systems. Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products, Understands internal/external Regulatory environment. Actively builds an organizational network. Communicates across GSK, with minimal input from manager regarding projects and new requirements impacting MSR deliverables

Educational Background :

Bachelor\xe2\x80\x99s 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.

Appropriate for the role

Masters degree or higher in biological or healthcare science

Regulatory, Pharmaceutics, or other related science or regulatory affairs. Project Management, Communication

Job-Related Experience :

• Minimum 1 - 6 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.

Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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