Strategic Regulatory Lead
4 dni temu
- Act as Global Regulatory Lead: Drive matrix team engagement for CEP portfolio assets and take ownership of lifecycle maintenance, including discontinuation of Marketing Authorizations (MAs).
- Lead Communication with Regulatory Agencies: Be the main point of contact with the European Medicines Agency and other European Local Health Authorities for National, Centralised and Mutual Recognition procedures products.
- Ensure Regulatory Strategy Delivery: Guarantee that the regulatory strategy meets the needs of global and regional commercial and supply chain projects while considering local market needs.
- Cultivate Relationships with Stakeholders: Foster productive relationships with internal teams, including regulatory labelling, CMC, medical, commercial, supply chain, and clinical teams.
You will also be responsible for taking proactive initiatives to identify and escalate crucial issues early on and contribute to crafting solutions. Additionally, you will ensure compliance with global/regional regulatory life-cycle requirements and deliver health authority commitments.
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Global Regulatory Operations Leader
4 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout the RoleWe are seeking a skilled and experienced Global Regulatory Operations Leader to join our team at GlaxoSmithKline (GSK). As a key member of our organization, you will be responsible for overseeing the strategic management and continuous improvement of our User Access Management (UAM) application and X-Vault platform.This role is critical in...
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Strategic Manager for User Access Management
4 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout the RoleWe are looking for an experienced Strategic Manager to lead our User Access Management (UAM) and X-Vault Platform initiatives at GlaxoSmithKline (GSK). As a key member of our organization, you will be responsible for developing and implementing strategic plans to drive process improvements and innovation.This role requires a strong...
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Regulatory Information Management Lead
1 dzień temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatThe Senior Manager, RIM & Data Office at GlaxoSmithKline is responsible for ensuring the delivery of RIM initiatives and projects. This includes overseeing operational teams and leading matrix teams across the broader Regulatory Information Management & Data Office and Global Regulatory Operations group, globally.You will work closely with Global Regulatory...
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Director of Regulatory Operations
5 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout the RoleWe are seeking a highly skilled Senior Manager, Regulatory Operations to lead our Veeva Regulatory Vault team. As the Business System Owner (BSO), you will be responsible for overseeing the strategic management and continuous improvement of this business-critical system.As BSO, you will ensure that Reg Vault is effectively supporting global...
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Regulatory Systems Manager
5 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout UsGSK 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 positively impacting the health of billions of people and delivering stronger, more sustainable shareholder returns.We are seeking a highly skilled Senior Manager, Regulatory Operations to join our...
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Strategic Technology Lead
5 dni temu
Poznań, Greater Poland TN Poland Pełny etatThe Strategic Technology Lead position at TN Poland is an exciting opportunity to lead and grow our tribe's technology capabilities. As a key member of our team, you will drive the execution of our technology strategy and architecture, working closely with product teams to deliver effective solutions.You will provide technical consultation, decision support,...
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Regulatory Systems Business Owner
4 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout the RoleWe are seeking a highly skilled Regulatory Systems Business Owner to join our team at GlaxoSmithKline (GSK). As a key member of our organization, you will be responsible for overseeing the strategic management and continuous improvement of our User Access Management (UAM) application and X-Vault platform.This role requires a deep understanding...
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Regulatory Project Manager
4 tygodni temu
Poznań, Greater Poland TN Poland Pełny etatJob DescriptionWe are seeking an ambitious Regulatory Project Manager to lead the development of regulatory strategies and their execution for assigned assets, ensuring compliance with internal GSK processes and external regulatory requirements.The successful candidate will create a place where people can grow, be their best, be safe, and feel welcome,...
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Strategic Business Recovery Consultant
20 godzin temu
Poznań, Greater Poland TN Poland Pełny etatAs a Strategic Business Recovery Consultant, you will play a critical role in helping clients overcome financial difficulties and achieve their business goals. With a minimum of 10 years of experience in corporate finance, you will have a deep understanding of financial markets, debt instruments, corporate restructuring, private equity fundraising, and...
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Poznań, Greater Poland GlaxoSmithKline Pełny etatAt GlaxoSmithKline (GSK), we are seeking a talented Senior Manager to join our team as the Business System Owner for Veeva Regulatory Vault. As a key member of our regulatory operations team, you will be responsible for overseeing the strategic management and continuous improvement of this critical business system.This role is instrumental in ensuring that...
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Global Regulatory Compliance Specialist
1 dzień temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatThe Senior Manager, RIM & Data Office at GlaxoSmithKline is responsible for ensuring the timely execution of RIM based requests and delivery of RIM initiatives and projects. This includes overseeing operational teams and leading matrix teams across the broader Regulatory Information Management & Data Office and Global Regulatory Operations group,...
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Regulatory Affairs Specialist
1 dzień temu
Poznań, Greater Poland Randstad Polska Sp. z o.o. Pełny etatWe are seeking a highly skilled CMC Regulatory Expert to join our team at Randstad Polska Sp. z o.o.Job Description:Manage multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharmaceutical, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers)Lead...
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Project Management Lead
7 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatRegulatory Project and Resource Manager Job DescriptionThis role involves developing and managing integrated Regulatory Development Plans (RDPs) that align with Global Regulatory Strategy, ensuring accurate capture of regulatory deliverables, timelines, and resource needs for each phase of development. You will work closely with Regulatory Matrix Teams and...
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CMC Regulatory Expert
1 dzień temu
Poznań, Greater Poland Randstad Polska Sp. z o.o. Pełny etatAs a Senior Compliance Specialist, you will be responsible for managing multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharmaceutical, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers).About the Job:Lead assigned projects: define and agree...
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Pharmaceutical Regulatory Professional
1 dzień temu
Poznań, Greater Poland Randstad Polska Sp. z o.o. Pełny etatWe are looking for a Regulatory Affairs Specialist to join our team at Randstad Polska Sp. z o.o.About the Role:Manage multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharmaceutical, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers)Lead...
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Strategic Product Lead
4 dni temu
Poznań, Greater Poland Allegro Group Pełny etatWe are seeking a skilled Senior Product Manager to lead our Merchant Listing (Adding Offers and Products) area. The ideal candidate will have a strong focus on both merchant experience and ensuring the highest quality of offers and products.Key Responsibilities:Develop and optimize solutions for adding offers via Flat Files (Excel, CSV) and other input...
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Regulatory Affairs Expert
5 dni temu
Poznań, Greater Poland TN Poland Pełny etatJob DescriptionWe are seeking a Senior Regulatory Specialist to join our Polish Hub. This role is responsible for coordinating and developing the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.The successful candidate will be accountable for overall work plans and accountable to individual GRLs/TGs...
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Senior Manager, UAM and X-Vault Platforms
4 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout the RoleWe are looking for an exceptional Senior Manager to lead our UAM and X-Vault Platforms team at GlaxoSmithKline (GSK). As a key member of our organization, you will be responsible for driving strategic initiatives and managing the end-to-end lifecycle of these critical systems.This role requires a strong understanding of regulatory operations,...
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Regulatory Compliance Expert
5 dni temu
Poznań, Greater Poland LiNA Medical ApS Pełny etatProduct Development OpportunityLiNA Medical ApS invites applications for a Product R&D Engineer position, offering a unique chance to drive innovation and improve product development. As a key member of our interdisciplinary team, you will contribute to the creation of cutting-edge medical devices and collaborate with cross-functional teams to ensure...
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Strategic Marketing Sourcing Expert
5 dni temu
Poznań, Greater Poland TN Poland Pełny etatAbout the RoleThis is an exceptional opportunity for a highly motivated and experienced procurement professional to join our team in TN Poland. As a Category Manager for Marketing Procurement, you will be responsible for driving procurement excellence and delivering sustainable results.Key Objectives:Develop and execute procurement strategies that drive...