Senior Regulatory Executive. Moscow (Pharmaceuticals)
• Preparation of high quality, Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources. liaising closely with other GSK personnel to ensure accuracy of such records.
• Working to agreed deadlines and maintaining records to reflecting project status
• Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice
• Post Approval CMC experience preferential
• CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations
• Experience responding to manufacturing site change controls and providing regulatory advice and strategies
• Detailed proven CMC knowledge and experience for EU and EMAP region
• Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
• Ability to manage multiple project assignments/teams simultaneously and provide data assessment and conclusions
• Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
• Ability to efficiently interact with customers and senior stakeholders as required
• Good communication skills and flexible approach - " can do attitude"
Fluent English as a must
• CMC experience
• Good written and oral communication and networking skills
GlaxoSmithKline Pharmaceuticals - is one of the world's leading over-the-counter pharmaceutical companies, including vaccine unit, clinical research and medicines for HIV/infectious diseases treatment (ViiV Healthcare).
Our aim - to help as many people as possible do more, feel better, live longer.
Our company operates in more than 150 countries around the world.
GSK prescription medicines are intended for treatment of a wide range of acute and chronic diseases (COPD, Asthma), including a number of rare diseases (Pulmonary Arterial Hypertension, Systemic lupus erythematosus).
You may apply for this position online by selecting the Apply now button.
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