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Senior Regulatory Affairs Executive
Location:
Maidenhead
Description:
Senior Regulatory Affairs Executive An exciting opportunity for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team. This individual will be responsible for providing analytical insight for new products under development, site transfers and life cycle management of Marketing Authorisation. Responsibilities : Work within Regulatory, providing technical support for new marketing authorisation applications, life cycle management and response documents to Regulatory Authority. : Review product development reports, analytical data of new development projects and provide technical guidance on robustness/improvements where required to development teams. : Support Head of RA/Line Manager to design, execute remediation experiments and implement changes to existing methods : Ensure regulatory compliance of organisation's product Marketing authorisations keeping track of compendial changes, backssing physicochemical analytical methods, executing method revisions and improvements where appropriate and submit changes to Regulatory Authority in a timely manner. : Review Module 3 CTD dossier for completeness and correctness of data/documents. : Author and submit module 3 sections of Regulatory applications. : Critically review RFI and contribute in submitting response to queries regarding analytical methods/specification/validations. : Participate and play key role in product technology transfers to contract manufacturing organisations (CMOs to CMOs) and at own manufacturing site in accordance with the product licences and GMP Guidelines. : Review and technically approve documentation including but not restricted to Protocols, Validation Reports, Specifications, methods, : Provide technical guidance in the understanding of root causes for out of trend or out of specification results or deviations arising during process validation, source/process changes, stability. : Provide. Visit ListedBuy for more information.
Posted:
April 23 on ListedBuy
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Senior Regulatory Affairs Executive is a Other Art & Media Jobs Executive Job located in United States. Find other listings like Senior Regulatory Affairs Executive by searching Oodle for Other Art & Media Jobs Executive Jobs.