Regulatory Compliance Associate; Generic Pharma

Regulatory Compliance Associate (Generic Pharma)

Job Title:

Regulatory Compliance Associate (Generic Pharma)
Company:
Granules Consumer Health LLC (subsidiary of Granules India LTD)

Location:

Manassas, VA

Granules Consumer Health LLC is a vertically integrated pharmaceutical company headquartered in Hyderabad, India, with 106 employees and annual revenue of $76.64 million. The US division serves as Granules’ front‑end for private‑label, over‑the‑counter (OTC) generic products, delivering high‑quality generics at affordable cost.

• Subject matter expert for global labeling requirements for OTC and ANDA products marketed by Granules USA.
• Establish labeling strategy and requirements for customer labels; serve as the primary contact for label‑related requests.
• Responsible for drug listing of Granules USA‑marketed products.
• Review and approve product labeling and maintain labeling database.
• Assist in leading regulatory training on labeling requirements, including advertising and promotional material.
• Approve labeling to ensure compliance with corporate, regulatory, safety, and legal requirements.
• Initiate change control to ensure regulatory assessments are identified, documented, and implemented.
• Coordinate regulatory submissions for ANDA products to be packaged at contract packagers.
• Review and approve artwork files on various customer artwork portals (i.e., CVS, Walmart, Rite Aid, Walgreens, etc.).
• Provide support to QA as needed.
• Other tasks assigned by manager.
• Prepare and maintain internal regulatory databases.

• Bachelor’s degree in life sciences (or equivalent work experience) with a minimum of 3 years of experience, or a master’s degree with 1 year of pharmaceutical manufacturing experience, and at least 1 year of experience in a progressive, challenging RA labeling department within the pharmaceutical industry.

Mid‑Senior level

Full‑time

Finance and Sales

Manassas, VA — $75,000–$80,000