Senior Regulatory Specialist

Responsibilities: In this position you will provide regulatory representation on product development teams. Prepare and coordinate successful regulatory strategies for products that ensure timely regulatory approvals, both domestically and internationally. Assess regulatory reporting requirements for changes made to development or commercialized products. Coordinate and prepare quality regulatory submissions. Provide sound regulatory guidance to internal and external customers. Participate on product development core team(s) as the regulatory representative. Prepare and coordinate successful strategies that ensure timely and financially sound regulatory approvals (U.S. and International). Assess regulatory reporting requirements for changes (e.g. manufacturing, labeling) that affect development or commercialized products. Provide recommendations on labeling, manufacturing, marketing, R&D study plans and clinical study design to ensure regulatory compliance. Coordinate and prepare both hardcopy and electronic information packages for regulatory submissions (U.S. and International). Ensure product license renewal and annual registrations. Provide regulatory guidance and training to other departments, external partners or other Regulatory Affairs personnel as requested. Interact with regulatory authorities. Keep abreast of emerging regulatory policy changes that affect current and future regulatory strategies/reporting requirements. Prepare internal department procedures for continuous process improvement. Supervise the activities of other lower-level personnel as assigned. Perform other related duties as assigned.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