Aktualne oferty pracy związane z Regulatory Systems Business Owner Leader - Poznań, Greater Poland - GlaxoSmithKline
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Regulatory Systems Business Owner Leader
2 tygodni temu
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together.
We are committed to delivering high-quality products to patients worldwide while ensuring the highest standards of regulatory compliance and operational efficiency.
About the Role:This role is a key part of our regulatory operations team, responsible for ensuring that Veeva Regulatory Vault meets the needs of our global regulatory operations and compliance requirements.
The successful candidate will have expertise in Veeva Regulatory Vault, including key objects, Dynamic Access Control, and assessing validation impacts of Veeva releases.
Responsibilities:- Regulatory Systems Management: Oversee the management, maintenance, and optimization of key regulatory business systems to ensure they meet the needs of regulatory operations and compliance requirements.
- Collaboration and Innovation: Foster collaboration with other BSOs and systems, drive innovation, and align with GSK's regulatory strategy.
- Project Management: Oversee the planning, execution, and delivery of projects related to regulatory system enhancements, upgrades, and new implementations, ensuring they are completed on time and within budget.
- Stakeholder Communication: Serve as the key point of contact for regulatory system-related matters, providing regular updates and communications to senior management, stakeholders, and regulatory authorities as needed.
Requirements:
- Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, Regulatory Affairs, Information Technology, or a related discipline.
- Relevant professional certifications such as Regulatory Affairs Certification (RAC), Project Management Professional (PMP), or certifications in IT systems management or data governance.
- Expert-level knowledge of Veeva Regulatory Vault, including key objects, Dynamic Access Control, and assessing validation impacts of Veeva releases.
- Extensive experience delivering business operational support to critical regulatory systems in a global environment.
