Regulatory CMC Liaison / Biologics

Our client is a leading global pharmaceutical company.  They have asked us to assist them in their search for candidates to fill role of Regulatory CMC Liaison – Biologics. 

The successful candidate will:

• Provide biologics-specific regulatory advice and creative solutions to fellow members of the Regulatory CMC Group, based on his/her wealth of experience 

• Formulate, lead and drive regional and/or global CMC regulatory biologics strategy for assigned development projects and/or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance. 

• Proactively provide strategic input and communicate critical topics in adequate and timely manner to interdisciplinary project teams and to appropriate management level. 

• Lead, implement and drive CMC submission activities (planning, review, coordination, submission) for assigned projects/products. Make quality regulatory decisions as necessary, balancing risks and benefits. 

• Represent Regulatory CMC in interdisciplinary regulatory and technical project teams. 

• Establish and maintain a single point of contact with internal and external partners and customers for all communication on development projects and marketed products. Establish and maintain sound working relationships with partners and customers. 

• Lead cross-functional Health Authority response teams for assigned development projects, as appropriate.