Regulatory Associate II CMC

Recruiter
i Pharm Consulting
Location
Bedfordshire
Posted
05 Oct 2017
Closes
02 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
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 nbehan@i-pharmconsulting.com. 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