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Associate Director, Global Regulatory Affairs-CMCRef: 24608

Salary:£70000 - £80000 per annum + bonus, car allowance, stocks, pension

Added:04 Oct 2019

Region: South East

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

My client, a medium sized bio-pharmaceutical company in the Oxfordshire area,is looking for an Associate Director of Global Regulatory Affairs (CMC). This will be open as a permanent role and working across regulatory submissions , late and early stage and leading multi-disciplinary teams in essential business projects. Responsibilities: -Planning and coordinating the authoring/reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions -Provide in-depth reviews of protocols, reports, presentations and preempting internal/external business challenges or regulatory issues. -Interpret complex technical or supply issues for commercial/development programs -Regular interaction with functional leaders/major customers -Development of departmental strategy -Monitor EU and US CMC Regulations Candidate Profile: - Applicable knowledge of CMC regulatory - eCTD CMC regulatory documents (MAA, BLA, Variations, Responses, CTAs/INDs) - FDA, EMA and ICH guidelines Education: - BSc/BA with a minimum of eight years of regulatory CMC experience

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