Skip navigation
Unable to save this job. Please try again later.


Email this Job to Yourself or a Friend

To begin the application process, please enter your email address.

Company Contact Info

  • 6500 Rock Spring Drive
    Bethesda, MD 20817

Already have an account?

Sign in to apply with your saved resumes.

New to CareerBuilder?

Don't have an account? Continue as a guest!

Sorry, we cannot save or unsave this job right now.

Report this Job

Trust and Site Security Team.

Don't miss out on new jobs!

Get the latest Director of Regulatory Affairs jobs in Bethesda, MD delivered directly to your inbox. You can unsubscribe at any time.

Saving Your Job Alert

Job Alert Saved!

Could not save Job Alert!

You have too many Job Alerts!

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.

Sign Up

or   Sign In Here
Password Must Contain
8 to 15 characters
1 uppercase letter
1 number or symbol
1 lowercase letter
Create an Account with CareerBuilder to save jobs & unlock these great features
See similar job titles and skills to help you make your next move
Upload a resume and become visible to Hiring Managers and Employers
Compare Salary Information to see where you stand amongst your peers
Easily Quick Apply to jobs with just one click!

Email Send Failed!

Associate Director, Regulatory

Technical Resources International • Bethesda, MD

Posted 7 days ago

Job Snapshot

Degree - Graduate Degree
Biotechnology, Pharmaceutical
Government - Federal
Relocation - No

Job Description

Founded in 1979, Technical Resources International, Inc. (TRI) is a full-service contract research organization plus (CRO+) providing product development support services to the global drug, biologic, and medical device community through the effective combination of scientific, clinical information technology, and communications services. TRI, Inc. is currently seeking an Associate Director, Regulatory.




  • Manages and/or supervises a Team of Regulatory Managers, Regulatory Specialists, Regulatory Operations Associates, and Human Subjects Protection Specialists 
  • Assists in managing the overall process of regulatory submission preparation and review, including Investigational New Drug applications (INDs), Annual Reports to INDs, Investigator’s Brochures (IBs) and other regulatory documents 
  • Ensures high quality work products are consistently delivered on time to the client, the FDA, and other Regulatory Health Authorities.   
  • Supports the Department Director in ensuring 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 
  • Supports the development of the Standard Operating Procedures (SOPs) that support the Regulatory Affairs operations 
  • Interacts with study sponsors, project managers, clinical research staff and Food and Drug Administration (FDA)/other Regulatory Health Authorities to ensure timely receipt and submission of information required for regulatory submissions 
  • Coordinates professional development as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients 
  • Assists the Department Director with staff hiring, training and recruitment strategies, and staff performance evaluations  
  • Develops and implements project plans, procedures, and work instructions for new statements of work for existing and new clients 
  • Supports the preparation and review of technical proposals


Job Requirements

  • Ph.D. with related experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, regulatory affairs, or other, applicable field
  • Strong scientific, regulatory affairs, clinical research, and/or project management background. 
  • Solid working knowledge of drug development process and FDA regulatory requirements 
  • Strong management and leadership skills; experience in leading regulatory operations/submissions teams a plus 
  • Direct experience interacting with government regulatory authorities a plus 
  • Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well. 
  • Proficient in Microsoft office; experience with SharePoint a plus. 
  • Superior organizational skills and customer service abilities. 
  • Ability to analyze medical research data and review experimental protocols. 
  • Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards is a plus. 
  • Able to exercise initiative and sound judgment, and to prioritize ongoing projects. 


Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.


Job ID: 201910
Help us improve CareerBuilder by providing feedback about this job: Report this Job.
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.
Don't miss out on new jobs like this
Get the latest jobs delivered to your inbox. Unsubscribe at any time.

Saving Your Job Alert

Job Alert Created

Well, this is embarrassing. We are having trouble saving your search. You can try again or come back at a later time.

Maximum Email Alerts

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.