Senior Manager, Global Regulatory CMC Biologics - Switzerland
My client, a large pharmaceutical company is looking for a Senior Manager, Global Regulatory CMC Biologics to join their team in one of their sites located in Switzerland. To find out more about the role and company please call Nikolay on +41 (0)44 580 3717 / +49 (0)69 222 22 888 or send your CV to Nikolay.dimitrov@secpharma.com
As a Senior Manager, Global Regulatory CMC Biologics you will provide strategic and operational global CMC regulatory direction for assigned biologic projects through development, registration and life cycle management.
Responsibilities:
-Formulate, lead and drive global CMC regulatory strategy for assigned development projects and/or marketed products in Biologics
-Proactively communicate CMC regulatory strategy to interdisciplinary project teams and to appropriate management level
-Lead and implement all global CMC submission activities while applying the global strategy into submissions
-Author high-quality CMC documentation for Health Authority submission
-Single point of contact with internal and external partners for all communication on development and/or marketed products
-Initiate and lead Health Authority interactions and negotiations
-Lead cross-functional Health Authority Response Teams
-Represent Reg CMC in interdisciplinary regulatory and technical project teams
Minimum Requirements:
-Degree in Science (e.g. Biotechnology, Biochemistry, Biology, Cell Biology) or equivalent. Advanced degree is preferred!
-4-6 years in regulatory preferred, and experience in biologic pharmaceuticals
-Working knowledge/experience in regulatory submission and approval processes for New Chemical Entities (NCE) and product life cycle management
-Proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements
-Proven track record of successfully working in interdisciplinary teams, and of planning, coordinating and leading activities simultaneously on multiple projects
-Demonstrated ability for strategic thinking, maintaining awareness of business impact
-Demonstrated ability for risk assessment and mitigation
-Strong interpersonal, communication, negotiation and problem solving skills
-Fluent English required (oral & written)
Nikolay Dimitrov
Pharmaceutical Division
Tel:
+44 (0)20 7255 6665
+33 (0)170807489
+49 (0)69 222 22 888
+41 (0)44 580 3717
Email: Nikolay.Dimitrov@secpharma.com
Web: www.secrecruitment.com
