Regulatory CMC Liaison/Biologics

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 a wealth of experience.  The incumbent will also 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.  The candidate will proactively provide strategic input and communicate critical topics in an adequate and timely manner to interdisciplinary project teams and to appropriate management level personnel.  Will lead, implement and drive CMC submission activities (including planning, review, coordination and submission) for assigned projects/products.  Will make quality regulatory decisions as necessary, balancing risks and benefits.  The incumbent will represent Regulatory CMC in interdisciplinary regulatory and technical project teams.  Will also establish and maintain a single point of contact with internal and external partners and customers for all communication on development projects and marketed products.  As well as establish and maintain sound working relationships with partners and customers.  The candidate will lead cross functional health authority response teams for assigned development projects, as appropriate.  Requirements for this position include a relevant scientific degree in biotechnology, biochemistry and cell biology or equivalent.  Good communication skills, both oral and written.  Several years experience in regulatory preferred.  Excellent working knowledge in regulatory submissions and approval processes and the ability to deal with complex CMC regulatory issues and requirements.  The candidate must also have a strong background in biopharmaceutical developement (e.g. cell culture, downstream processing, analytics).  Biologics experience is desired.  The incumbent must also have a proven track record in successfully leading/working in interdisciplinary teams, and of planning, coordinating and leading activities simultaneously on multiple projects.  Requirements also include strong interpersonal, organizational, communication, presentation, negotiation and problem solving skills.

Please refer to job code SD6501 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Livingston, NJ
County:	Essex County
ZIP Code:	07039
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856