Regulatory Affairs Specialist

On behalf of our client we are now looking for a Regulatory Affairs Specialist to work with and to inform of Chemistry, Manufacturing and Controls (CMC) documentation for worldwide registration of commercial products. Accountabilities/Responsibilities: - To produce CMC documentation to an agreed content and timetable from technical data. Gain cross-functional approval for delivery of the documentation to Global Regulatory Affairs for world-wide use in registration applications. - May manage the process required to reach cross-functional agreement on responses to regulatory queries and provide the agreed responses to Global Regulatory Affairs for onward transmission to regulatory authorities. - Using Business Wide electronic systems, maintain the regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs so that the Operations Function has access to its past, current and approaching regulatory commitments in the manufacture and supply of commercial products. - May contribute to IT system development and maintenance, ensuring that any work is carried out according to approved procedures. - Share experiences and contribute to establishment of best practices within CMC RC. Requirements: -An academic degree in Chemistry, Pharmacy or Biology - Experience from working within Pharmaceutical companies - Experience from Regulatory affairs and CMC - IT Software skills (XML/Word Processing) - Excellent written and verbal English Skills and Capabilities: -Customer focused and performance driven -Analytical thinking and flexible -Concern for people - Concern for standards - Team Working skills -Influencing Skills