Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents. Support CMC development activities from a regulatory standpoint du...
In this role, a typical day might include the following:Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and info...
Regulatory Affairs Certification (RAC) is a plus. Demonstrated expertise in preparing CMC sections of regulatory submissions (, INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (, FDA, EMA, Health Canada, PMDA). Strong understanding of global regulatory requirements, gui...
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings with country specific regulatory mentorship documents. The candidate will be leading the regulatory strategies for biologic products ...
Regulatory Affairs Certification (RAC) is a plus. Demonstrated expertise in preparing CMC sections of regulatory submissions (e. Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e. Experience with regulatory submissions ...
We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. May act as a submission compliance liaison with other areas of Regulatory A...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
Group Benefits Compliance Manager. This role involves managing the compliance program for the Group Benefits business, which includes products like stop loss, li. ...
Position OverviewAs a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obligations of those requirements, and support the business in understanding the evolvi...
Position OverviewAs a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obligations of those requirements, and support the business in understanding the evolvi...
Cherry Hill Programs brings the magic to every experience by capturing moments that last a lifetime. In partnership with retail locations, tourist attractions and destinations across North America, Cherry Hill Programs contributes millions of holiday and souvenir experiences for children and familie...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests, and supporting other departments within the organization. Ability to review regulatory and scientific submission documents ...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge...
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
This management position in Regulatory Affairs involves the ability to lead and manage a Therapeutic Area (TA) within Regenerons Regulatory Affairs organization so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to...
A typical day might include the following:Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supplyCollaborates cross-functionally to support the submission strategies and impacts on supply and regul...
Kimley-Horn's White Plains, New York (NY) office is seeking a Civil Engineering Project Manager with 10+ years of experience to join their Water/Wastewater and Utilities team! This is not a remote position. Managing project tasks, project design and permitting, construction coordination, and providi...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
As a Regulatory Specialist (also known as Regulatory Affairs Specialist, Compliance Specialist), you'll play a crucial role in ensuring that our cosmetic products comply with all applicable regulations and standards. Your responsibilities will include monitoring and interpreting relevant regulations...
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Job Description: Anti-Fraud Team is looking for an Analyst and Associate level compliance Business analyst to support a project. The Analyst will be working on a project within the Anit-Fraud team. ...