Regulatory Affairs Specialist
3 weeks ago
This 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, notifications, labelling updates, renewals, and sunset clause management.
Key Skills and QualificationsRequired skills include a strong understanding of GMP, Quality, and Regulatory requirements, as well as proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools.
The ideal candidate will be able to communicate effectively with a range of stakeholders, both internally and externally, and maintain awareness of changing regulatory requirements.
For further information, please contact the relevant personnel within Achieva Group Limited.
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Regulatory Affairs Specialist
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St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager 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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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.Key ResponsibilitiesThe successful candidate will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations, notifications, labelling updates,...
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