Senior Regulatory Executive
2 months ago
Senior Regulatory Executive
Contribute to Cross-functional Teams and Build Regulatory Expertise.
In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.Represent Regulatory on product based teams.Provide regulatory input to commercial strategic and operating planning process.Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary.Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.Build personal expertise through management of specified products within one or more therapy areas.Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.Work with regional strategists to provide country input into Global and European Regulatory Strategies as required.Seek to improve alignment of local and regional regulatory strategy and tactics.
Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
Manage and Submit Marketing Authorisation Applications:
National/MRP/Decentralised MAA:
Centralised MAA
Manage and Submit MA Variation Applications
Manage and Submit MA Renewal Applications
Management of Safety Reports and Issues with Regulatory Authorities
Influence Regulatory Authorities
Manage Clinical Trial Approvals
Populate and Maintain Regulatory Databases
Obtain Authority Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)
Safeguard Compliance and Manage Packaging and Prescribing Information Component updates
Manage and Submit MA Variation Applications
Manage and Submit MA Renewal Applications
Management of Safety Reports and Issues with Regulatory Authorities
Influence Regulatory Authorities
Manage Clinical Trial Approvals
Populate and Maintain Regulatory Databases
Obtain Authority Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)
Safeguard Compliance and Manage Packaging and Prescribing Information Component updates
Implement MA Divestments, Cancellations and product Discontinuations
Contribute to Good Regulatory Practice (appropriate for all tasks)
Support Regulatory Group Development
Lead Personal Development
Support to Third Party Licences
Devices
QUALIFICATIONS
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Senior Regulatory Executive
2 months ago
Tadworth, Surrey, United Kingdom Pfizer Full timeSenior Regulatory ExecutiveContribute to Cross-functional Teams and Build Regulatory Expertise. In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.Represent Regulatory on...
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EU Regulatory Strategy Lead
4 weeks ago
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Regulatory Affairs Specialist
2 days ago
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Regulatory Affairs Specialist
2 days ago
Tadworth, Surrey, United Kingdom Pfizer Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Global Regulatory Sciences team, you will be responsible for representing the EU region in regulatory matters related to our early-stage oncology portfolio.Key ResponsibilitiesDevelop and implement EU regulatory strategies in...
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Senior Associate, early phase oncology, Regulatory
2 months ago
Tadworth, United Kingdom Pfizer Full timeJob Summary Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in...
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Head of EU Regulatory Affairs for Oncology
4 weeks ago
Tadworth, Surrey, United Kingdom Pfizer Full timePosition Overview The EU Regulatory Strategy Lead will serve as the primary representative for the European Union (EU) regulatory strategy pertaining to the early phase Oncology portfolio. This role is critical in shaping and overseeing the development of regional strategies while collaborating with the Global Regulatory Strategic Team (GRST). Key...
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EU Lead
2 months ago
Tadworth, United Kingdom Pfizer Full timeJob Summary Primary representative for EU (EU, UK, CH, AUS, NZ) regulatory strategy for the designated early phase Oncology portfolio, Oversee and contribute to the development of EU regional strategies for the designated early phase Oncology portfolio as a member of the Global Regulatory Strategic Team (GRST). Lead, oversee, and/or implement EU...
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Senior Estates Manager
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Senior Estates Manager
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Senior Estates Manager
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Senior Estates Manager
5 days ago
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Senior Manager
2 months ago
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Quality Assurance Project Manager
1 week ago
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Quality Assurance Project Manager
1 week ago
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Test and DevOps Manager
2 days ago
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Test and DevOps Manager
2 days ago
Tadworth, Surrey, United Kingdom People Source Consulting Full time{"Role": "Senior Test and DevOps Manager", "Location": "Surrey", "Salary": "Competitive", "Job Description": "We are seeking an experienced Senior Test and DevOps Manager to lead the Testing and DevOps operations within our dynamic team. This role ensures the successful delivery of high-quality software and embedded products through efficient testing...
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Tadworth, Surrey, United Kingdom SRG Full timeJob Overview:SRG is seeking a highly skilled and experienced Medical Quality Governance Project Coordinator to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and governance in our medical projects.Key Responsibilities:Project Management: Utilize your exceptional project...
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Tadworth, Surrey, United Kingdom SRG Full timeJob Overview:SRG is seeking a highly skilled and experienced Medical Quality Governance Project Coordinator to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and governance in our medical projects.Key Responsibilities:Project Management: Utilize your exceptional project...
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Events Executive
3 months ago
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Marketing Associate Manager
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