Regulatory Affairs CMC Director
Alameda, California
SUMMARY/JOB PURPOSE: Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects. Develop strategic approaches to enable succesful Health Authority submissions and communications. Work closely with...
18m
| Job Type | Full Time |
Regulatory Affairs Strategy Manager (Oncology)
Alameda, California
SUMMARY/JOB PURPOSE: Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions and preparing amendme...
18m
| Job Type | Full Time |
Senior Regulatory Affairs Project Manager I
Austin, Texas
ICON is seeking a highly motivated and dedicated Project Manager to work at the intersection of structural design and testing, overseeing the testing process for validation and regulatory acceptance of ICON's breakthrough 3D-printed structu...
24d
| Job Type | Full Time |
Senior Regulatory Affairs Project Manager I, MILCON
Austin, Texas
ICON is seeking a highly motivated and dedicated Sr. Regulatory Affairs Project Manager, MILCON to advance regulatory acceptance and business development across federal government and national security sectors, including the Department of D...
24d
| Job Type | Full Time |
Vaccines Manager, Global Regulatory Affairs
Rockville, Maryland
Job Description Do you have experience in all aspects of a Regulatory Affairs project, supporting technical/ CMC, clinical, nonclinical and procedural aspects of strategy and submissions, but are looking to take this to the next level, supp...
25d
| Job Type | Full Time |
Vaccines Senior Manager, Global Regulatory Affairs
Rockville, Maryland
Job Description Are you a subject matter expert in technical / CMC and procedural aspects of Global Regulatory Affairs, driven to provide in-depth input into asset specific regulatory strategy on a global scale for clinical/labelling or tec...
25d
| Job Type | Full Time |
Director, Regulatory Affairs Strategy
Cambridge, Massachusetts
Who is BlueRock? BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investiga...
19m
| Job Type | Full Time |
Quality Assurance and Regulatory Affairs Manager
Grand Rapids, Michigan
About UFP MedTech: UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply ...
25d
| Job Type | Full Time |