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Regulatory Affairs and Compliance Manager Pharmaceuticals Global pharmaceutical leader seeks a Regulatory Affairs and Compliance manager to lead a compliance and regulatory affairs team responsible for writing and filing regulatory submissions. The Regulatory ...
Description BASIC PURPOSE:Drive the Quality agenda for Beverage Innovation in the areas including, but not limited to, natural/all natural ingredients, recovery ingredients, organic sweeteners and other critical focus areas. This role is a key enabler to ...
General Manager of Laboratory Operations Life Science Based in Chicago, Illinois (Northern suburb of Chicago in Lincolnshire, IL Our client is a global leader in inspection and testing services with over 59,000 employees and 1000 offices and labs worldwide. ...
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Description Basic RoleSr. Manager, WW (WorldWide) Technical Support This position will lead all technical aspects of SSM B&C (Bottle & Can) PET (Polyethylene terephthalate) commercial support. The team relies on this position in order to achieve PET commercial ...
For your reference, we have included the original job posting below.
Manager, Regulatory Affairs
Job Number:
25715548
Company Name:
Biogen Idec
Job Location:
Cambridge, MA US
Job Category:
Healthcare & Medical
Manager, Regulatory Affairs
Job Title Manager, Regulatory Affairs Location US-MA-Cambridge Job Category Regulatory Requisition Number 13140BR Job Description The Manager, Regulatory Labeling is responsible for strategy development and risk assessment of activities in support of labeling development. This person will integrate overall business objectives into departmental goals and actions while integrating into cross-functional teams that establish regulatory strategy for drafting global labeling. Within cross-functional teams, this person establishes regulatory strategy for developing core labeling documents. This position influences regulatory agencies, professional organization and other functional teams within Biogen Idec in matters related to labeling.
.Develop regulatory strategy and tactics for developing core labeling documents .Establish innovative strategies for achieving regulatory compliance for labeling .Establish parameters for labeling and influence teams to share a common vision .Strategically assess labeling activities and influence cross-functional team decision making for these activities .Execute effective decision-making, planning and project management in the development of labeling .At end of Phase 3 development, establish strategy for developing US labeling assuring cross-functional consensus Qualifications Ideal candidate will have a minimum of 6 years regulatory or relevant industry experience, including 2 years management experience. .Experience in interpretation of labeling regulations .Experience in interfacing with FDA .Demonstrate excellent leadership and communication skills .Ability to represent the department on cross-functional teams .Ability to build capability through coaching and mentoring Education BS/BS University degree required. Life/Health sciences preferred
