Director - Regulatory Affairs

Responsibilities: Kforce is currently recruiting for a Director of Regulatory Affairs to join a pharmaceutical company in the Orange County area. The Director, Regulatory Affairs, is primarily responsible for establishing the regulatory affairs strategy associated with the product development cycle of sterile injectable products. In addition, the responsibility extends to managing the Regulatory Affairs department to assure that the department accomplishes its functions adequately and has resources to meet company objectives. This role also provides leadership with regard to regulatory affairs best practices in the sterile injectable arena. Responsibilities include: Establish and communicate Regulatory Affairs strategies and tactics for sterile injectable products to meet company and corporate objectives. Act as primary contact representing Regulatory Affairs for the site for both government and business interactions, possessing signature authority as the company's Regulatory Affairs authority. Manage all projects assigned to the Regulatory Affairs department and the associated budget approved by the company. Advise the company and corporate management on Regulatory Affairs matters as requested and when changes occur in the regulatory landscape with potential impact to the business. Hire, manage, and train Regulatory Affairs staff, conduct performance reviews, handle dispute resolution, enforce Human Resource policies within the department, etc. Follow Safety, Health, and Environmental policies and procedures. Complete other duties, as assigned, or as business needs require.If you are not a local candidate but are relocating, please inform me of your arrangements (i.e., date and city/state you are relocating to).Kforce (NASDAQ: KFRC) is a full-service specialty staffing firm providing flexible and permanent staffing solutions for organizations and career management for individuals in the specialty skill areas of information technology, finance & accounting, human resources, engineering, pharmaceutical, health care and scientific. Backed by more than 1,500 recruiting specialists, Kforce operates in more than 40 markets in North America. For more information, please visit our web site at