Regulatory Associate II CMC

i Pharm Consulting
05 Oct 2017
02 Nov 2017
Contract Type
Full Time
Senior Regulatory Associate A fantastic opportunity for a Regulatory Professional to join a global CRO. You will Provide regulatory strategy for CMC submissions worldwide and with guidance author and review Module 3 sections. Must be eligable to work in the UK.JOB TITLERegulatory Associate II CMCLOCATIONBerkshireBENEFITSGenerous SalaryExcellent on-going career development opportunitiesBenefitsJOB DESCRIPTION• Conducts CMC change control assessments• Provides regulatory strategy of CMC submissions worldwide• Authors and reviews Module 3 sections• Prepares and reviews CMC documentation required to support submissions e.g IMPD updates, MAA, post approval variations and renewals. REQUIRED EXPERIENCE: • Knowledge of variations/renewals/procedures in Europe and/or emerging markets• Complete understanding of the content and typical level of detail in Module 3. • Conducted CMC Change Control Assessment – determine if regulatory action is required and if so determine the strategy, documentation requirements and timelines;• Preparation of technical justifications to support variations – prepared in collaboration with technical experts• Manage cross functional interactions with supervision to support CMC activities;• Prepare and review Module 3 CTD sections for regulatory submissions (variations, renewals, responses to RA assessments); • Experience of product development/manufacturing or analytical work is strongly preferredMINIMUM EDUCATION • Bachelor of Science Degree in life science related discipline• Minimum 2 years regulatory CMC experience, focusing on marketed products in Europe and/or emerging marketsABOUT i-PHARM CONSULTINGi-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.www.i-pharmconsulting.comTO APPLYIf you would like to discuss this vacancy further, please call Principal Consultant Niall Behan on +44 (0)20 3189 0463, or email If this role is not suitable, Niall is also available to discuss other possible positions or answer any general questions regarding your career and the current market.KEY WORDS/ Regulatory Affairs Associate / Regulatory Associate / Regulatory Affairs / Regulatory Lead / UK / Ireland / Dublin / Post-Approval/ MAA / Regulatory Affairs / London / Berkshire / Regulatory Affairs / CRO