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`Regulatory Affairs Manager

Quality & Laboratory
Dublin South
Siobhán Lane
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Job Reference: JO-2011-65475_1605884214



· Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements

· Organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products

· Act as key RA CMC representative on product deviation investigation teams

· Participates in site change control teams


· Bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology or related discipline)

· 5 years of direct experience

· Candidates must have GMP site experience

· Strong knowledge of and experience in CMC

· Proficient use of MS Office tools, SharePoint and strong computer aptitude.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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