As Director, Regulatory Affairs/Labeling, lead a labeling team with responsibility for preparation of labeling for new products for inclusion with Worldwide Marketing Applications, and revised labeling for marketed products; presentation of proposed labeling to the Merck Labeling Committees for review and approval; and preparation of labeling for submission to Health Authorities and/or subsidiaries worldwide. Develop labeling strategy and ensure strategic alignment and consistency across the labeling for assigned portfolio of products. Determine timelines for labeling deliverables for regulatory filings, approvals and compliance activities, and ensure that such timelines are met.
Manage compliance and quality activities for assigned team
Qualifications
Education Requirement:
B.S. in a scientifically or medically-related discipline.
Master's Degree preferred.
Required Experience:
Minimum of 10 years pharmaceutical experience. Minimum of 5 years labeling experience. Prior management experience required. Proven ability in medical writing. Process improvement, and compliance/quality experience. Experience leading teams, driving consensus and results. Excellent leadership, communication and collaboration skills.
Preferred Experience:
Industry experience in the cardiovascular/metabolism and primary care therapeutic areas.
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