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...
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 ...
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 for ...
Regeneron is seeking a highly motivated and experienced Associate Director of CMC Regulatory Sciences to join our global team. As an Associate Director of CMC Regulatory Sciences your remit will include the following:. Leading and managing the global CMC Regulatory Sciences Post-Approval Commercial ...
This role is responsible for the preparation of various regulatory Labeling submissions and as well as review of labeling documents for submission. Electronically search for new regulatory guidelines and regulations. Solid review, writing and communication skills and the ability to work independentl...
The Associate, Regulatory Affairs will work with Regulatory Counsel in regulator and entity relationships, cover important legislative and regulatory hearings and meetings as assigned, and supports the Regulatory Affairs function by serving as an enterprise wide resource on public policy and IDR tre...
The Regulatory Associate will report to the Senior Manager, Regulatory Affairs and, under the direction and guidance of the Associate Vice President, will help to ensure regulatory compliance of Prestige marketed products. Assist with regulatory affairs projects and initiatives as needed, including ...
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...
Regeneron is seeking a highly motivated and experienced Associate Director of CMC Regulatory Sciences to join our global team. As an Associate Director of CMC Regulatory Sciences your remit will include the following:. Leading and managing the global CMC Regulatory Sciences Post-Approval Commercial ...
Troubleshoot location challenges with compliance program platform, maintaining compliance etc. Under moderate supervision, ensures First Student's driver, monitor, technician, and staff maintain compliance under Federal/State/contractual rules and regulations. Upload and compliance date maintenance ...
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...
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...
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...
Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders. Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working gr...
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 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...
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...
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...
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...
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 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...
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...