DIRECTOR RA BASE BUSINESS Job
Johnson & Johnson
Job Code - 56208
Position - See job description
Job First Active on: Thursday, February 23, 2012
DIRECTOR RA BASE BUSINESS
Ethicon, Inc, a Johnson & Johnson Company is recruiting a Director, Regulatory Affairs, Base Business, to be located in Somerville, NJ.
Ethicon, Inc., a Johnson & Johnson company, is a trusted, world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the company's vision: Restoration of Body and of Life.
The U.S. Johnson & Johnson Wound Management (JJWM) Regulatory Affairs Director will provide strategic regulatory management and leadership to the Ethicon JJWM business unit and the Ethicon franchise Regulatory Affairs Department, managing approximately four direct reports. The Director will be responsible for assuring development and execution of optimal regulatory strategies, key interface with FDA and all other regulatory agencies for all Ethicon JJWM base business projects appropriate for the category of project - device, biologic or combination biologic/device. In addition, the Director will be responsible for maintaining the approvals/clearances through copy review, required reports and other regulatory submissions. The Director will liaise with business unit teams to ensure projects are adequately staffed and managed, proceed on time, and within the designated budget; identify and manage initiatives to improve department capabilities. The Director will ensure consistent global regulatory approach for Ethicon JJWM products.
Accountable for global regulatory strategy for all Ethicon JJWM base business projects appropriate for the category of project - device, biologic, combination biologic/device. Ensures successful execution of regulatory strategy including regulatory agency interface, submissions and reports for Ethicon JJWM projects. Ensures a consistent approach to global regulatory strategy for the Ethicon JJWM business. Accountable for maintenance of the global approvals/clearances through copy approval, FDA inspection support, and required agency reports and post-approval submissions. Implement Regional RA strategy by transferring registration ownership from Israel to U.S. and help build capability to sustain global RA strategy. Meet current defined RA milestones for JJWM.
REQUIREMENTS - QUALIFICATIONS: DIRECTOR RA BASE BUSINESS
Minimum of Bachelor's (BS or BA) degree in Life Sciences or Engineering is required, advanced degree preferred. Regulatory Affairs Certification (RAC) preferred. Minimum 5 years regulatory experience is required Experience in the biopharmaceutical, pharmaceutical, or medical device industry is preferred. Must possess experience with CBER, CDRH or CDER. Broad experience in all areas of Regulatory Affairs related to biopharmaceuticals is preferred. People management experience is required.· Ability to build collaboration and teamwork across the Ethicon JJWM business, both commercial and functional. Strong communication and negotiation skills. Strong people development skills. Critical thinking and decision making skills. Ability to lead teams through change and transformation. Travel 10-15%
Johnson & Johnson
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