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Regulatory Affairs Specialist

Job

Merit American technologies inc

Irving, TX (In Person)

$72,000 Salary, Full-Time

Posted 3 weeks ago (Updated 2 days ago) • Actively hiring

Expires 8/5/2026

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Job Description

$98k Per Year Position range in Dallas County $46k - $91k Per Year Regulatory Affairs Specialist Merit American technologies inc
Occupation:
Compliance Officers
Location:
Irving, TX - 75062
Job Type:
Regular, Full Time (30 Hours or More), Permanent Employment, Day Shift
Posted:
06/16/2026 Positions available: 1
Source:
WorkInTexas
Web Site:
WorkInTexas Onsite /
Remote:
Work onsite all of the time
Updated:
06/19/2026
Expires:
07/18/2026 Job #: 17028075 Job Requirements and Properties Help for Job Requirements and Properties. Work Onsite Full Time Education Master's Degree Experience 12 Month(s) Schedule Full Time Job Type Regular Duration Permanent Employment Hours 40 Hours Per Week Shift Day Shift Help for . Create submissions of Advertising and Promotional (Ad/Promo) materials to Office of Prescription and Drug Promotion (OPDP), division of the U.S. Food and Drug Administration (FDA). Process and publish submissions for Subpart H and Subpart E to OPDP. Prepare, review, and publish Advisory comments, correspondences, and TV commercial submissions to OPDP. Work on different simple, medium, and complex level submissions of various products promotional material types like Websites, Videos, Exhibits, Formulary Kits, Direct Mail, Print Ads, Slides, Electronic Detail Ads etc. Maintain promotional document and submission metrics; archive OPDP pieces and submissions. Participate in cross-functional Alignment meetings with Marketing and Ad/Promo teams and analyze the current workflow processes to improve and develop the overall 2253 promotional materials submission process. Compile the dossier in the required format of submission to the relevant agencies. Bookmark and hyperlink pdf documents using ISI Publisher tool. Prepare and submit 1571, 356h, 2252 submissions as per the requirements in association with the Regulatory team. Support with IND, NDA and BLA submissions for various health agencies (US and Canada). Work under supervision. Travel and/or relocation to unanticipated client sites throughout USA is required.
EXPERIENCE OF TWELVE
(12)
MONTHS IN REGULATORY AFFAIRS IS REQUIRED. PRIMARY REQUIREMENTS
MASTER'S
DEGREE IN CHEMISTRY/PHARMACY OR CLOSELY RELATED FIELD
 WITH TWELVE (12) 
MONTHS OF EXPERIENCE IN THE JOB OFFERED OR AS A
 REGULATORY
AFFAIRS SPECIALIST OR VERY CLOSELY RELATED
AREA.