Regulatory Compliance Associate (Generic Pharma) jobs in United States
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Granules Pharmaceuticals, Inc. · 5 hours ago

Regulatory Compliance Associate (Generic Pharma)

positionManassas, VA
timeFull-time
remoteOnsite
seniorityMid Level
date3+ years exp

Granules Pharmaceuticals, Inc. is a vertically integrated pharmaceutical company located in Manassa, Virginia. They are seeking a Regulatory Compliance Associate to serve as a subject matter expert for labeling requirements and to ensure compliance with regulatory standards for OTC and ANDA products.

Pharmaceuticals
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H1B Sponsor Likelynote

Responsibilities

Subject matter expert (SME) for global labeling requirements for OTC and ANDA Products marketed by Granules USA
Establish labeling strategy and requirements for customer labels and serves as the primary contact for customer label related requests
Responsible for Drug listing of Granules USA marketed products
Review and approves product labeling and maintain labeling database
Assists in leading regulatory training on labeling requirements including advertising promotional material
Approves labeling to ensure compliance with corporate, regulatory, safety and legal requirements
Initiates change control to ensure regulatory assessments are identified, documented and implemented
Responsible for coordinating regulatory submissions for ANDA products to be packaged at contract packagers
Reviewing and approving artwork files on various customer artwork portals (i.e., CVS, Walmart, Rite Aid, Walgreens, etc.…)
Providing support to QA as needed
Other assigned tasks by manager
Prepare and maintain the internal Regulatory Databases

Qualification

Regulatory complianceLabeling strategyPharmaceutical manufacturingRegulatory submissionsCommunication skills

Required

Bachelor's degree in the life sciences (or equivalent work experience) with a minimum of 3 years or master's degree with 1 year of pharmaceutical manufacturing experience
At least 1 year of those years in a progressive challenging RA labeling department in the pharmaceutical industry

Company

Granules Pharmaceuticals, Inc.

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Granules Pharmaceuticals, Inc. is a pharmaceuticals company based out of 3701 CONCORDE PKY, Chantilly, Virginia, United States.
dateFounded in 2014
location
Chantilly, Virginia, US
people-size51-200 employees

H1B Sponsorship

Granules Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (7)
2023 (22)
2022 (24)
2021 (10)
2020 (19)

Funding

Current Stage
Growth Stage

Leadership Team

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Gregory B. Reeves
Chief Human Resources Officer
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Company data provided by crunchbase