Job Description
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 â€" Biologics.
The successful candidate will:
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Provide biologics-specific regulatory advice and creative solutions to fellow members of the Regulatory CMC Group, based on his/her wealth of experience
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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.
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Proactively provide strategic input and communicate critical topics in adequate and timely manner to interdisciplinary project teams and to appropriate management level.
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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.
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Represent Regulatory CMC in interdisciplinary regulatory and technical project teams.
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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.
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Lead cross-functional Health Authority response teams for assigned development projects, as appropriate.
Job Requirements
We seek candidates who meet these minimum requirements:
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Relevant 4-year scientific degree in biotechnology, biochemistry and cell biology or equivalent.
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7-10 years of experience in regulatory preferred.
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Excellent working knowledge/experience in regulatory submissions and approval processes for Biopharmaceuticals and ability to deal with complex CMC regulatory issues and requirements
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Strong background in biopharmaceutical development (e.g. cell culture, downstream processing, analytics). Biologics experience desired.
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Proven track record in successfully leading/working in interdisciplinary teams, and in planning, coordinating and leading activities simultaneously on multiple projects.
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Strong interpersonal, organizational, communication, presentation, negotiation and problem solving skills.
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Fluent English language skills, oral & written.
Do you have the skills and experience we seek and want to advance your career with a leading company? If so, please email your resume as a Word attachment to [Click Here to Email Your Resumé] , reference code 2360-CB. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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