Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Rn - Registered Nurse - Quality Improvement - Regulatory Affairs - Am
Recruited by University of Alabama at Birmingham 9 months ago
Address , Birmingham
Regulatory Affairs Manager Jobs
Recruited by DHL 9 months ago
Address , Westerville, 43082
Regulatory Affairs Specialist Jobs
Recruited by AM Logic Corporation 9 months ago
Address , Edison, 08820, Nj
Rn - Registered Nurse - Quality Improvement - Regulatory Affairs - Am (002)
Recruited by UAB Medicine 9 months ago
Address , Birmingham, Al
$60,835 - $98,855 a year
Regulatory Affairs Specialist 3 - Remote
Recruited by The Cooper Companies 9 months ago
Address , Trumbull, Ct
$92,847 - $125,000 a year
Regulatory Affairs Manager Jobs
Recruited by DHL 10 months ago
Address Westerville, OH, United States
Regulatory Affairs Specialist 2 Jobs
Recruited by Yale University 11 months ago
Address , New Haven, 06511, Ct
Specialist, Regulatory Affairs Jobs
Recruited by Chanel 1 year ago
Address , Piscataway, 08854, Nj
Regulatory Affairs Specialist Jobs
Recruited by Laborie Medical Technologies 1 year ago
Address , Portsmouth, 03801, Nh
Regulatory Affairs Specialist Jobs
Recruited by Technical Resources International, Inc. 1 year ago
Address , Bethesda, 20817, Md
Us Regulatory Affairs Summer Intern
Recruited by Johnson & Johnson 1 year ago
Address , Somerville, 08876, Nj
$29 an hour
Director, Regulatory Affairs Jobs
Company | Technical Resources International, Inc. |
Address | , Bethesda, 20817, Md |
Employment type | FULL_TIME |
Salary | |
Expires | 2023-06-12 |
Posted at | 1 year ago |
- Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
- Ensures compliance with the applicable domestic and international regulations and guidelines including Good Manufacturing Practice (cGMP), current Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and providing support for TRI’s internal Quality Assurance Program/Quality Systems.
- Manages the overall process of regulatory submission preparation and review, including Investigational New Drug applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), investigational device exemption (IDEs), Annual Reports, and other regulatory documents.
- Participates in the preparation and review of technical proposals.
- Manage the development of the Standard Operating Procedures (SOPs) that support the Regulatory Affairs operations.
- Supervises Regulatory Affairs managers, and, where no manager is assigned, Regulatory staff directly.
- Interacts with study sponsors, project managers, clinical research staff and Food and Drug Administration (FDA) to ensure timely receipt and submission of information required for FDA submissions.
- Provide guidance for resource and development planning.
- Superior organizational skills and customer service abilities.
- Proficient in Microsoft office; experience with SharePoint a plus.
- Solid working knowledge of drug development process and FDA regulatory requirements.
- Ph.D., Pharm D., or M.S. or equivalent related experience in science (biology, chemistry, biochemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, toxicology), regulatory affairs, or another applicable field.
- Strong management and leadership skills; experience in leading submissions teams.
- Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
- Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
- Strong scientific, regulatory affairs, clinical research, and/or project management background.
- Solid working knowledge of ex US regulatory requirements preferred.
- Direct experience interacting with government regulatory authorities preferred.
Get job alerts by email. Sign up now! Join Our Talent Network!
Job Snapshot
Employee Type
Full-TimeLocation
Bethesda, MDJob Type
BiotechExperience
Not SpecifiedDate Posted
04/03/2023Job ID
678/228/1104-
Systems Analyst - Excel, Xml, Sql, Scripting
By CyberCoders At Salt Lake City, UT, United States 8 months ago
-
(Senior) Finance & Shared Services Manager
By Catholics For Choice At Washington, DC, United States 8 months ago
-
Paralegal - Probate Administration
By CyberCoders At Miami, FL, United States 8 months ago
-
Account Executive - Automotive Software
By ECW Search At United States 8 months ago
-
Construction Project Coordinator Jobs
By CyberCoders At River Falls, WI, United States 8 months ago