Regulatory Affairs Manager

Job Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team in GSK's Global Regulatory Centres. The successful candidate will be responsible for managing multiple CMC new files and CTA assignments for Pharma, Biopharm, and Vaccines products.Your Key Responsibilities:Defining and agreeing regulatory strategies to ensure...

About the RoleWe are seeking a highly skilled Regulatory Portfolio Manager to join our team at TN Poland. As a key member of our regulatory affairs department, you will be responsible for ensuring the development and execution of regulatory strategies for our Classic & Established Product (CEP) portfolio.Your primary objective will be to maintain compliance...

Job 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...

We 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...

Job OverviewThis is an exciting opportunity for a Senior Regulatory Affairs Professional to join our team at Allegro. The successful candidate will be responsible for ensuring that our operations are in line with regulatory requirements.The ideal candidate will have a solid understanding of compliance and adapting the company to legal acts. Experience...

Job OverviewWe are seeking a seasoned Senior Regulatory Specialist to join our Polish Hub team. The successful candidate will be responsible for leading the development and implementation of the CTA/IND lifecycle strategy.Key Responsibilities:Coordinate and refine the CTA/IND lifecycle strategy, ensuring timely delivery and compliance with GSK...

About 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...

At 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...

Job 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,...

Regulatory 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...

We 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...

About the Job:We are looking for a talented CMC Regulatory Expert to support our Global Regulatory Centres in GSK. The ideal candidate will have extensive experience in regulatory affairs, pharmaceutical industry, and familiarity with CMC regulatory procedures and ICH CTD documentation.Key Requirements:Bachelor's or Master's degree in biotechnology,...

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...

About 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...

The Senior Regulatory Specialist, Country Labelling will play a key role in ensuring that all labelling documents and related materials meet the highest standards of quality and compliance. This includes coordinating with internal stakeholders to gather necessary information and conducting thorough reviews to ensure accuracy and completeness. The role will...

As 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...

Job RequirementsTo succeed as a Regulatory Project and Data Manager, you will need strong project management skills and the ability to work with stakeholders spanning multiple functional areas. You will also require a broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives, as well as relevant...

Job OverviewGSK is seeking a dedicated Regulatory Project and Data Manager (RPDM) to support our team in the planning and resource management for Rx and Vx projects from Commit to Candidate (C2C) through post-approval R&D activities. The RPDM will work closely with Regulatory Matrix Teams and Early/Medicine Development Teams.The ideal candidate will have...

The 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...

The 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,...