Regulatory Compliance Associate; Generic Pharma

Description

Granules Consumer Health LLC is a subsidiary of Granules India LTD, a vertically integrated pharmaceutical company with headquarters in Hyderabad, India. Granules Consumer Health LLC is located in Manassa, Virginia. We have 106 employees and annual revenue of $76.64 million. We serve as Granules’ front-end division for private label over the counter (OTC) products in the US. We offer OTC generics that meet the highest level of quality at an affordable cost.

As such, we are well-established on bulk supply through efficiencies garnered through manufacturing, integration and a high level of regulatory compliance. We are dedicated to excellence in manufacturing, quality, and customer service.

• 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.

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