US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - San Diego
As the Director of Regulatory Affairs, the responsibilities consist of leading an entire function for a sub-region or significant business unit; or leads a sub-function for a division or major region; or is a global leader for a major team. Develops policies and authorizes / guides their implementation.Oversees and directs all regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies.
Creates and drives strategy for the area of responsibility with some operational and tactical responsibility.
Regularly interacts with senior leadership, requiring negotiation and influence on critical policy-making decisions (internal and external).
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements.
Regularly interacts with executives and/or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization.
Directs and controls the activities of a broad functional area through several department managers within the company. Has overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods.
Requires strong leadership skills and clear, open, transparent communication skills
Provide oversight and direction for US regulatory strategy and execution
Provide oversight and direction for OUS regulatory strategy and execution
Provide regulatory strategies in communication with research and development and marketing departments
Oversight and guidance with respect to tissue regulatory compliance and new product development, including expansion of indications
Minimum of 15 years of related experience with a Bachelor’s degree; or 12 years and a Master’s degree; or a PhD with 8 years experience; or equivalent experience.
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