The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). More Years of direct regulatory affairs experience, including US labeling expe...
This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). More Years of direct regulatory affairs experience, including US labeling expe...
This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. Reporting t...
Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals. Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. ...
On-Board Scientific is hiring a Regulatory Affairs Assistant!. The Regulatory Assistant needs to exhibit working knowledge of pharmaceutical operations. The Regulatory Assistant will need to utilize scientific and technical information to ensure that documents produced are consistently accurate and ...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory ...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory ...
Pharmaceutical company looking for an experienced Quality Assurance and Regulatory Affairs Associate. Ideal candidates should have experience within QA and/or Regulatory Affairs department in a pharmaceutical or R&D company. Under the supervision of the Head of QA/RA, the QA/RA Associate is responsi...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory ...
Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals. Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. ...
This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. Reporting t...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory ...
Center 1 (19052), United States of America, McLean, VirginiaSenior Manager, Technical Program Management, Bank TechAre you interested in leading programs that deliver on critical business goals and build large scale products & platforms?About Capital One: At Capital One, we’re changing banking for g...
Center 3 (19075), United States of America, McLean, VirginiaSenior Manager, Technical Program ManagerAre you interested in leading programs that deliver on critical business goals and build large scale products & platforms?About Capital One:At Capital One, we’re changing banking for good. Highly tun...
Center 1 (19052), United States of America, McLean, VirginiaSenior Manager, Technical Program Manager - Machine LearningAre you interested in leading programs that deliver on critical business goals and build large scale products & platforms?At Capital One, we believe that Machine Learning (ML) repr...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Partner with Regulatory Reporting Analysis team members to understand current reporting procedures and manual processes performed to file regulatory reports (FR Y-9C, FR Y-11, FR Y-15, FFIEC 009, FFIEC 002). Draft reporting requirements for various regulatory reports (specific to SMBCAH data availab...
Are you a passionate IT trailblazer – a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working....
Responsible for effective financial regulatory reporting operations for the US Branch & BHC, including the production of high quality financial regulatory reports, maintenance of an effective regulatory reporting platform, and an internal control framework designed to mitigate risk, enhance the accu...