Regulatory Affairs Specialist
7 days ago
We are seeking a skilled Regulatory Affairs Manager to join our team at Achieva Group Limited. This is a fantastic opportunity for an experienced professional to take on a challenging role and contribute to the success of our organization.
Key Responsibilities- Manage post-approval changes of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clause management across our product portfolio.
- Maintain MIA and WDA, including API import registration.
- Develop and implement filing strategies and manage submission timelines.
- Identify and remediate compliance gaps as needed.
- Gather, consolidate, and analyse documentation for regulatory filings.
- Coordinate and prepare written responses to requests for information from regulatory authorities.
- Monitor the status of regulatory applications.
- Review and assess the regulatory impact of change control/requests for the manufacturing, testing, and release of drug substance and drug product.
- Strong understanding of GMP, Quality, and Regulatory requirements.
- Excellent communication and stakeholder management skills.
- Proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools.
- Maintenance of awareness of changing regulatory requirements.
The salary for this position is approximately £60,000 - £80,000 per annum, depending on experience.
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Regulatory Affairs Specialist
1 month ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Achieva Group Limited. The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.Key ResponsibilitiesManage post-approval filings and life cycle maintenance supplements of Marketing...
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Global Regulatory Affairs Specialist
10 hours 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 Specialist
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St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeThis role is responsible for overseeing the post-approval lifecycle of Marketing Authorisations, ensuring compliance with regulatory requirements.Key ResponsibilitiesThe successful candidate will be accountable for:Maintaining and updating Marketing Authorisation files, including variations, notifications, and labelling updates.Coordinating and preparing...
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Regulatory Affairs Specialist
4 weeks ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeThis role is responsible for managing post-approval changes of Marketing Authorisations and product life cycle management for Achieva Group Limited.Key ResponsibilitiesThe successful candidate will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations,...
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Regulatory Affairs Specialist
4 weeks ago
St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeThis role is responsible for overseeing post-approval changes to Marketing Authorisations and product life cycle management across the product portfolio.Key ResponsibilitiesThe successful candidate will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations,...
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Regulatory Compliance Expert
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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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