Senior Regulatory Affairs Professional

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...

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...

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...

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...

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 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,...

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...

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...

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...

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...

We are looking for an experienced Compliance Program Manager to join our team at Revalize, Inc.As a leading provider of sector-specific software solutions, we help manufacturers optimize revenue operations through design applications, engineering simulations, product selection, CPQ, PIM, visualization, and data analytics.This role will require close...

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...

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...

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,...

Job Title:Senior Specialist SRA Central Europe (f/m/x)Company:Mars WrigleyDepartment:Scientific and Regulatory AffairsWork Arrangement:Hybrid workingKey Responsibilities:Ensure ingredients, formulas, labelling, and packaging comply with laws, regulations, and internal standards/policies in assigned markets.Verify claims are compliant with laws, regulations,...

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...

Why Choose Us?We offer a dynamic and supportive work environment that fosters growth and development. Our team is committed to delivering high-quality work and making a positive impact on patients' lives.As a Senior Regulatory Specialist, you will have the opportunity to work on challenging projects, develop your skills and expertise, and make a meaningful...

Company OverviewGSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with...

The role of a Pharmaceutical Regulatory Professional is to 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).About the Position:Lead assigned projects: define and agree...