Regulatory Compliance Associate
3 days ago
About the Role
We are seeking an experienced QA Affiliate to join our team at Astellas Europe. As a key member of our Quality team, you will be responsible for ensuring compliance with Good Distribution Practice Guidelines (GDP Guidelines) and supporting the Responsible Person Import (RPi) and the QA Lead in meeting their responsibilities and accountabilities.
The role involves performing and processing activities governed by GDP Guidelines, including QA oversight of product storage and distribution, nonconformance management, product complaint handling, change control, supplier management, and annual product review. The estimated salary for this position is around €58,000 - €68,000 per year, depending on location and experience.
Key Responsibilities:
- Perform and process activities governed by GDP Guidelines
- Implement improvements to correct inefficiencies and non-conformances
- Support inspection management for the wholesale dealer license
- Represent Affiliate QA in project teams and act as a role model for Quality Culture
Essential Knowledge & Experience:
- Relevant transferable skills in a comparable role in the pharmaceutical industry
- Understanding of implementation and understanding of GDP, GMP, and Quality Management Systems
- Good organizational, coordination, presentation, and communications skills
-
Regulatory Compliance Officer
1 month ago
Addlestone, Surrey, United Kingdom Brook Street Full timeAbout Our Client:The Veterinary Medicines Directorate plays a crucial role in the regulation of veterinary medicinal products, ensuring their safety and efficacy. As part of this team, you will work alongside scientific professionals, interact with the pharmaceutical industry, and coordinate with global regulatory bodies to facilitate the authorisation of...
-
Regulatory Compliance Specialist
4 weeks ago
Addlestone, Surrey, United Kingdom Brook Street UK Full time £18Brook Street is seeking a highly skilled Regulatory Compliance Specialist to join the Veterinary Medicines Directorate (VMD) in Addlestone, Surrey. As an Executive Officer in the Application Management Team, you will play a vital role in maintaining standards within veterinary medicine regulation.About the RoleThis challenging administrative position...
-
Regulatory Affairs Manager
4 weeks ago
Addlestone, Surrey, United Kingdom Brook Street UK Full timeJob Description:We are seeking a highly skilled Executive Officer to join our team at the VMD in Addlestone, Surrey.This is a challenging role that involves working closely with regulatory bodies to ensure compliance with veterinary medicines regulations.The successful candidate will have a strong understanding of regulatory affairs and be able to apply...
-
Senior Regulatory Affairs Specialist
5 days ago
Addlestone, Surrey, United Kingdom Lifelancer Full timeAstellas, a leading healthcare company, is seeking an experienced Senior Regulatory Affairs Specialist to join our team. This role will be based in the UK and will require a minimum of 2 days per week in the office.Job DescriptionThis is a permanent, full-time position that involves managing global registrations, ensuring compliance with EMA/FDA/ICH/global...
-
Global Regulatory Lead for CMC
3 days ago
Addlestone, Surrey, United Kingdom Astellas Europe Full timeAbout the JobWe are seeking a highly experienced Regulatory Affairs Expert to join our team in the UK. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regulatory strategies for our CMC products.Responsibilities:Developing and implementing global CMC regulatory strategies to ensure compliance with...
-
Regulatory Affairs Expert
3 days ago
Addlestone, Surrey, United Kingdom Astellas Europe Full timeThe RoleAs a CMC Regulatory Strategist, you will be responsible for developing global CMC regulatory strategy, driving global CMC RA related activities, and successfully executing regulatory strategies in collaboration with stakeholders.You will also be supporting business-critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC...
-
Lead Regulatory Pharmacovigilance Expert
4 weeks ago
Addlestone, Surrey, United Kingdom Lifelancer Full timeWe are seeking a highly skilled Lead Regulatory Pharmacovigilance Expert to join our team at Lifelancer.About the Role:The successful candidate will be responsible for leading the post-authorisation surveillance of veterinary medicines, ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Develop and implement strategies for...
-
CMC Regulatory Lead for Global Projects
54 minutes ago
Addlestone, Surrey, United Kingdom CTI Clinical Trial and Consulting Services Full timeKey ResponsibilitiesAct as a CMC regulatory lead/expert for global projects, ensuring compliance with EMA/FDA/ICH/global regulations.
-
Regulatory Compliance Specialist
4 weeks ago
Addlestone, Surrey, United Kingdom Brook Street UK Full time £18The Veterinary Medicines Directorate (VMD) is seeking a skilled Executive Officer to join the Application Management Team in Addlestone, Surrey.Key ResponsibilitiesCoordinate with global regulatory bodies to facilitate the authorisation of applications.Monitor application progress to maintain adherence to established procedures and timelines.Ensure data...
-
Addlestone, Surrey, United Kingdom Lifelancer Full timeWe are seeking a skilled Regulatory Affairs Director to lead our team in the life sciences industry. This is an exciting opportunity to shape the regulatory strategy and ensure compliance with relevant laws and regulations.About Us: Lifelancer is a talent-hiring platform that connects professionals with opportunities in pharma, biotech, health sciences,...
-
Addlestone, Surrey, United Kingdom Lifelancer Full timeAbout Lifelancer:Lifelancer is a leading talent-hiring platform in Life Sciences, Pharma and IT. We connect talented professionals with exciting opportunities in the pharma, biotech, health sciences, healthtech and IT domains.Job Title: Regulatory Affairs Lead, Chemistry, ManufacturingLocation: United KingdomWe are seeking an experienced Regulatory Affairs...
-
Regulatory Affairs Professional
11 minutes ago
Addlestone, Surrey, United Kingdom CTI Clinical Trial and Consulting Services Full timeJob DescriptionThe successful candidate will have a proven track record of successful health authority interactions and a strong understanding of global regulatory aspects for CMC across multiple dosage forms (oral and parenteral). They will be responsible for managing preparation and review of global registration packages, defining and implementing...
-
Addlestone, Surrey, United Kingdom Lifelancer Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Lead, Chemistry, Manufacturing to join our team at Lifelancer.Job Description:The successful candidate will be responsible for developing regulatory CMC strategy for assigned projects. This includes identifying and collecting CMC data required for regulatory submission packages, planning and...
-
Regulatory Compliance Specialist
3 days ago
Addlestone, Surrey, United Kingdom Astellas Europe Full timeJob DescriptionKey Responsibilities:Perform and process activities that are governed by GDP Guidelines as defined in the global Quality Management System.Support with inspection management for the wholesale dealer license.Represent Affiliate QA in recurrent project teams.Essential Knowledge & Experience:Relevant transferable skills in a comparable role in...
-
Administrative Team Manager
3 days ago
Addlestone, Surrey, United Kingdom Amber Employment Services Full timeRegulatory Applications Team LeadWe are seeking a skilled and experienced Regulatory Applications Team Lead to join our team at Amber Employment Services. As a key member of our team, you will be responsible for leading a specialist administrative team on a hybrid work pattern – 3 days in the office and 2 days working from home – for a 12-month...
-
Tax Review Professional
4 weeks ago
Addlestone, Surrey, United Kingdom Morson Talent Full timeTax Compliance RoleWe are looking for a skilled Tax Review Professional to join our client's Tax Compliance Team on an interim basis. As a key member of the team, you will be responsible for conducting tax reviews, reconciliating discrepancies, and ensuring compliance with regulatory requirements.About the PositionConduct detailed tax reviews and reconcile...
-
VAT Reconciliation Expert
4 weeks ago
Addlestone, Surrey, United Kingdom Morson Talent Full timeJob DescriptionThe role involves conducting comprehensive tax reviews, identifying discrepancies, and collaborating with stakeholders to ensure accurate reporting. As a VAT Reconciliation Expert, you will play a crucial role in maintaining the company's compliance standards.ResponsibilitiesConduct thorough tax reviews and analyze data to identify...
-
Executive Officer
4 weeks ago
Addlestone, Surrey, United Kingdom Brook Street UK Full timeAbout the Role:This is a fantastic opportunity to join the Veterinary Medicines Directorate (VMD) as an Executive Officer in the Application Management Team.The ideal candidate will have a strong background in administration and be able to work effectively in a team environment.The role involves providing administrative support to the team and ensuring...
-
Affiliate Quality Manager
3 days ago
Addlestone, Surrey, United Kingdom Astellas Europe Full timeAstellas Europe OverviewAstellas Europe is a leading healthcare company committed to delivering innovative solutions for patients with high unmet needs. Our team works closely with regulatory authorities and payers to ensure access to new therapies and support patient-centric culture.As the QA Affiliate, you will play a critical role in meeting the...
-
Construction Development Manager
2 days ago
Addlestone, Surrey, United Kingdom Crest Nicholson plc Full timeAvoidable Construction RisksTo ensure smooth operations, we require a skilled Technical Manager to oversee various aspects of construction, including site acquisition, technical investigation, and stakeholder engagement.The role entails:Collaborating with the Land Department to identify suitable development sitesDesigning and developing construction...