Director, Regulatory Affairs / Labeling

Merck is an innovative, global healthcare leader that is committed to improving health and well-being around the world.

As Director, Regulatory Affairs/Labeling, ensure strategic alignment and consistency across the labeling for assigned portfolio of products. Manage labeling staff 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.

• 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.
• Chair Merck Labeling Committee meetings to ensure that labeling is strategically aligned with and represents the labeling vision for the product including key labeling statements; global market positioning; and Merck corporate values, beliefs and position.
• Interaction with country-level Regulatory Affairs staff on key strategic labeling and regulatory issues. These interactions include management of the review of local country labeling by the Labeling Committees.

Education:

• B.S. in a scientifically or medically-related discipline
• Master's Degree preferred

Required:

• Minimum of 10 years regulatory affairs experience
• Minimum of 5 years labeling experience
• Minimum 2 years direct 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