Regulatory Affairs Director
2 days ago
Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management across our product portfolio.
Key Responsibilities:- Post-Approval Filings: Accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clause etc.
- MIA and WDA Maintenance: Responsible for maintaining MIA and WDA, including API import registration.
- Filing Strategy: Develop and manage submission timelines for regulatory filings.
- Compliance Gaps: Identify and remediate compliance gaps if any.
- Documentation and Submissions: Gather, consolidate, analyse documentation, and submit regulatory filings.
- Response to Requests: Coordinate and prepare written responses to requests for information from regulatory authorities.
- Status Monitoring: Monitor the status of regulatory applications.
The ideal candidate will have a strong understanding of GMP, Quality, and Regulatory requirements, with proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools. They should also be able to maintain awareness of changing regulatory requirements. We offer a competitive salary of £60,000 - £80,000 per annum, depending on experience.
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Regulatory Affairs Director
2 days ago
St Albans, Hertfordshire, United Kingdom CV Library Full timeAbout the Job:We are seeking a Regulatory Affairs Director to join our team at CV Library. As a key member of the financial services business, you will be responsible for providing compliance and risk services to ensure all relevant activities adhere to regulatory requirements.The successful candidate will report directly to the CFO and manage a small team....
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Regulatory Affairs Specialist
2 days ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeJob Title: Regulatory Affairs Specialist Achieva Group Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.About the RoleThe successful candidate will be accountable for the management of...
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Regulatory Affairs Engineer
4 days ago
St Albans, Hertfordshire, United Kingdom Premier Engineering Full timeRegulatory Affairs Engineer: We are seeking an experienced Regulatory Affairs Engineer to join our team at Premier Engineering. The successful candidate will have expertise in regulatory affairs and compliance within the engineering and manufacturing sector.About the Role: As a Regulatory Affairs Engineer, you will be responsible for ensuring that all...
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Regulatory Affairs Professional
3 weeks ago
St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full timeAt X4 Life Sciences, we are seeking a highly skilled Regulatory Affairs Specialist to oversee the entire lifecycle of Marketing Authorizations (MAs). This includes maintaining all aspects of MA maintenance, preparing and publishing documentation for Common Technical Documents (CTDs), implementing and communicating MA changes, collaborating with internal...
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Global Regulatory Affairs Specialist
4 weeks ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeAbout the RoleWe are looking for a talented Regulatory Compliance Expert to lead our regulatory affairs team. The successful candidate will have a strong understanding of GMP, Quality and Regulatory requirements.The estimated salary for this role is £65,000 per annum.
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Regulatory Affairs Lead
2 weeks ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeAchieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. The ideal candidate will have a strong understanding of GMP, Quality and Regulatory requirements.About the RoleThis position is responsible for post-approval changes of Marketing Authorisations, and product life cycle management. We are looking for someone with...
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Regulatory Affairs Manager
7 days ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeAircraft RegulatoryAbout the Role: Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team.Job Description: The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management. This includes accountable management of post-approval filings and life...
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Post-Marketing Regulatory Specialist
2 weeks ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeAchieva Group Limited is a dynamic company that is always looking for ways to improve. We are seeking a highly skilled Regulatory Affairs Manager to join our team and help us achieve our goals. The ideal candidate will have a strong background in Regulatory Affairs and excellent communication skills.About the RoleThis position is responsible for...
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Regulatory Compliance Expert
4 weeks ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeJob OverviewAchieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. This role offers a competitive salary of £65,000 per annum.In this position, you will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management across our product portfolio.
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Head of Regulatory Affairs
4 days ago
St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full timeAbout the RoleThis exciting opportunity is ideal for a seasoned Quality professional looking to take on a leadership position in a growing pharmaceutical manufacturer.Responsibilities:Continuously review and improve the quality management system to ensure compliance with regulatory requirements.Verify product quality and ensure adherence to GMP...
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International Tax Director
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Product Compliance Specialist
4 days ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeAs a Regulatory Affairs Manager at Achieva Group Limited, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the quality of our products. Your primary responsibilities will include managing post-approval changes of Marketing Authorisations and product life cycle management, as well as developing and managing...
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Compliance Coordinator
3 weeks ago
St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full timeX4 Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a vital role in ensuring the successful launch and maintenance of our products. Your expertise will be crucial in navigating the complexities of regulatory requirements and developing effective strategies to...
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MA Lifecycle Specialist
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St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full timeWe are looking for a seasoned Regulatory Affairs Specialist to join our team at X4 Life Sciences. As an essential member of our regulatory department, you will play a critical role in ensuring the successful launch and maintenance of our products. Your expertise will be instrumental in navigating the complexities of regulatory requirements and developing...
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Post-Marketing Change Manager
4 weeks ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeKey ResponsibilitiesAs a Global Regulatory Affairs Specialist, you will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations.This role offers a competitive salary of £65,000 per annum.
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Post-Marketing Change Coordinator
7 days ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeAchieve Excellence in Regulatory AffairsWe are seeking a talented individual to join our Achieva Group Limited team as a Post-Marketing Change Coordinator.Key Responsibilities: The ideal candidate will be accountable for management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations. This includes tasks such as...
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Global Compliance Manager
2 weeks ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeAchieva Group Limited is a leading company in the industry, and we are seeking a highly skilled Regulatory Affairs Manager to join our team. The ideal candidate will have a strong background in GMP, Quality and Regulatory requirements, as well as excellent communication skills.About the RoleThis position is responsible for post-approval changes of Marketing...
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Audit Director
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Senior Counsel
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St Albans, Hertfordshire, United Kingdom Tanner Pharma Group Full timeJob Description:We are seeking a Senior Counsel to join our legal and compliance team in St Albans. As a Senior Counsel, you will be responsible for advising on complex legal issues, drafting and negotiating international commercial contracts, and enforcing ethics and compliance requirements across our regional offices.About You:To be successful in this...
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Regional Support Manager
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