• Coordinate and prepare product submissions (pre and post market) for FDA and other major market regulatory agencies
• Create and maintain Technical Files, Design History Files, and Device Master Records
• Provide post market support for all...
Responsible for supporting the planning, oversight and implementation of clinical trial materials for multiple products conducted by Heron, spanning from the development of clinical material to meet clinical study needs, through the oversight of...
Works as part of the Regulatory Affairs department with direct responsibility for developing regulatory plans with high level of complexity. Plans and prepares documentation for international and domestic product registrations for new and...
Ajinomoto Althea, Inc.
Althea currently seeks a Quality Assurance Assistant for 2nd Shift!
The hours are 3:00 pm – 11:30 pm, M-F. As part of the training process, this candidate will need to have the flexibility to work 1st shift for the first 6 months. This is...
Ultragenyx Pharmaceutical Inc.
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in...
Bulletproof Documentation, Inc.
The contractor will support the new document creation process to meet the needs of the In Vitro Diagnostic (IVD) product schedule. In support of Premarket Approval (PMA), writer to develop a spectrum of quality and regulatory documents including but...
Theravance Biopharma US, Inc.
South San Francisco ,
The Associate Director will provide statistical leadership and technical expertise in support of post-marketing and clinical development activities for multiple therapeutic areas.
The Associate Director will be responsible to provide strategic and...
GQR GLobal Markets
My client an exciting and growing Biotech is looking for a Senior Manager of Analytical Development to be based in their Manufacturing facilities in Colorado.
You will be responsible for all analytical development efforts and the management of...
Sr. Regulatory Affairs Manager -Reg. Info Mgt. (RIM)
In early 2015, Actavis completed the acquisition of Allergan. This combination united two growing, successful and profitable companies into a unique, global pharmaceutical company and a...
The candidate will be responsible for performing and directing preclinical pharmacology studies for non-oncology indications, including in vivo studies in inflammatory and autoimmune disease models. Responsibilities include the development of...