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Senior Manager, Regulatory Affairs - Biologics and Base Business-7368131220
Description
Ethicon Biosurgery, a Johnson & Johnson Company, is recruiting a Senior Manager, Regulatory Affairs - Biologics and Base Business, to be located in Somerville, NJ.
Ethicon Biosurgery is a leading provider of proven solutions to address a range of bleeding and leaking situations - from routine to problematic -- during surgical procedures. These solutions can be used for open and minimally invasive procedures across broad range of specialties: cardiothoracic, cardiovascular, vascular, spine, neuro, GYN, urology, othropedic, ENT, bariatric, plastic and general surgery. Our product portfolio includes proprietary oxidized regenerated cellulose hemostats; gelatin powder and sponges; a flowable hemostatic matrix; human thrombin, and fibrin sealant. Additionally, Ethicon Biosurgery encompasses the Biopatch® line of business, an evidence-based dressing choice for local infections, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI in patients with central venous or arterial catheters. Ethicon Biosurgery is a division of Ethicon, Inc., a trusted leader in surgical care and part of the Johnson & Johnson Family of Companies. The company has been in operation for more than 50 years and is headquartered in Somerville, New Jersey.
The Senior Manager, Regulatory Affairs - Biologics and Base Business is responsible for assuring development and execution of optimal regulatory strategies, and interfacing with FDA and other regulatory agencies for biologics and combination biologic/device products. Ensures a consistent approach to global regulatory strategy for the Ethicon Biosurgery business. This individual is accountable for maintenance of global approvals/clearances, required reports and other regulatory submissions, FDA inspection support, required agency reports and post-approval submissions.
The Senior Manager, Regulatory Affairs - Biologics and Base Business is responsible for supporting broader business processes such as global product launch review approvals via internal systems, advertising/promotional approval and potential field actions. This individual liaises with business unit teams to ensure projects proceed on time and identifies and manages initiatives to improve department capabilities.
Qualifications
A Bachelor's degree and a minimum of 5 years of regulatory experience are required. A degree in a Life Science or Engineering is preferred. An advanced degree and Regulatory Affairs Certification (RAC) are assets. Experience in the biopharmaceutical, pharmaceutical, or medical device industry is preferred. Experience with CBER, CDRH or CDER is strongly preferred. Broad experience in all areas of Regulatory Affairs related to biopharmaceuticals is preferred.
The ability to build collaboration and teamwork across the Ethicon BIOSURGERY business, both commercial and functional is required. Strong communication and negotiation skills are required. Strong people development skills are required. Critical thinking and decision making skills are required. The ability to lead through change and transformation is required.
This position is located in Somerville, NJ. Up to approximately 15% domestic and international travel may be required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Job: Regulatory Affairs
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Senior Manager, Regulatory Affairs - Biologics and Base Business-7368131220
Description
Ethicon Biosurgery, a Johnson & Johnson Company, is recruiting a Senior Manager, Regulatory Affairs - Biologics and Base Business, to be located in Somerville, NJ.
Ethicon Biosurgery is a leading provider of proven solutions to address a range of bleeding and leaking situations - from routine to problematic -- during surgical procedures. These solutions can be used for open and minimally invasive procedures across broad range of specialties: cardiothoracic, cardiovascular, vascular, spine, neuro, GYN, urology, othropedic, ENT, bariatric, plastic and general surgery. Our product portfolio includes proprietary oxidized regenerated cellulose hemostats; gelatin powder and sponges; a flowable hemostatic matrix; human thrombin, and fibrin sealant. Additionally, Ethicon Biosurgery encompasses the Biopatch® line of business, an evidence-based dressing choice for local infections, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI in patients with central venous or arterial catheters. Ethicon Biosurgery is a division of Ethicon, Inc., a trusted leader in surgical care and part of the Johnson & Johnson Family of Companies. The company has been in operation for more than 50 years and is headquartered in Somerville, New Jersey.
The Senior Manager, Regulatory Affairs - Biologics and Base Business is responsible for assuring development and execution of optimal regulatory strategies, and interfacing with FDA and other regulatory agencies for biologics and combination biologic/device products. Ensures a consistent approach to global regulatory strategy for the Ethicon Biosurgery business. This individual is accountable for maintenance of global approvals/clearances, required reports and other regulatory submissions, FDA inspection support, required agency reports and post-approval submissions.
The Senior Manager, Regulatory Affairs - Biologics and Base Business is responsible for supporting broader business processes such as global product launch review approvals via internal systems, advertising/promotional approval and potential field actions. This individual liaises with business unit teams to ensure projects proceed on time and identifies and manages initiatives to improve department capabilities.
Qualifications
A Bachelor's degree and a minimum of 5 years of regulatory experience are required. A degree in a Life Science or Engineering is preferred. An advanced degree and Regulatory Affairs Certification (RAC) are assets. Experience in the biopharmaceutical, pharmaceutical, or medical device industry is preferred. Experience with CBER, CDRH or CDER is strongly preferred. Broad experience in all areas of Regulatory Affairs related to biopharmaceuticals is preferred.
The ability to build collaboration and teamwork across the Ethicon BIOSURGERY business, both commercial and functional is required. Strong communication and negotiation skills are required. Strong people development skills are required. Critical thinking and decision making skills are required. The ability to lead through change and transformation is required.
This position is located in Somerville, NJ. Up to approximately 15% domestic and international travel may be required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Job: Regulatory Affairs
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.