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For your reference, we have included the original job posting below.
Sr Manager, Regulatory Affairs
Job Number:
24258805
Company Name:
Biogen Idec
Job Location:
Cambridge, MA US
Job Category:
Healthcare & Medical
Sr Manager, Regulatory Affairs
Job Title Sr Manager, Regulatory Affairs Location US-MA-Cambridge Job Category Regulatory Requisition Number 12679BR Job Description The Senior 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 .6-8 years of Regulatory Experience .Minimum 4 years ALP 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
