Responsible for the coordination and preparation of document packages for regulatory submissions in one or more of the following geographic regions: United ...
GENERAL DESCRIPTION: Ensures regulatory compliance by completing the appropriate filings and documentation pertaining to incidents of injury, product approval ...
Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Ensure compliance with all ...
The Therapeutic Area team facilitates product development and global registration to achieve the desired regional labeling by developing and executing regulatory ...
Located in Fremont, CA at our growing Neurovascular Division; this role is responsible for the coordination and preparation of document packages for regulatory ...
This role will support one or more programs in the therapeutic Area team within Amgen's regulatory Affairs department. The Therapeutic Area team facilitates ...
The RA CMC Group is responsible for generation of the global regulatory strategy and providing feedback to the team for plans and execution of the strategy. ...
As part of a Regulatory team, manage clinical and nonclinical aspects for the priority development project in the company, an enzyme replacement therapy for ...
We are currently seeking a Executive Director, Regulatory Affairs for our Edison, New Jersey location. This position develops and executes Daiichi Sankyo Pharma ...
Group Purpose: To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation ...
To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global ...
The purpose of this group is to facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory ...
To facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for ...
Expertise with biologics and/or small molecule experience is essential. This position will manage CMC aspects of domestic and international regulatory affairs ...
Deerfield, IL Req ID 50910BR Business Title Project Leader, Clinical and Scientific Affairs, Cellular Therapies Business Corp Innovation and Development SubBusiness ...
