Regulatory Affairs Associate

Regulatory Affairs Associate

At Mindlance, we strive to deliver value through the combination of right people, processes, technologies and program management solutions. Our methods include- applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective All in all, our expertise lies in providing trained and committed minds to help meet your business objectives, irrespective of the stage your business is in.

Job Description

Job Title: Labeling Assistant Duration: 2 Months+ Location : Huntsville, AL

Summary: Mark up the labeling (container and insert labels) and communicate the changes to the labeling vendor. Proof read the labeling for accuracy and formatting upon receipt from the vendor. Process the final labeling for approval and transmit the approved labeling to the vendor and internally to other groups like QA etc. File the approved labeling per Qualitest procedures and policies.

Job Description:

• Performs routine cleaning and disinfection operations for the production support and process equipment according to Standard Operating Procedures (SOPs).
• Prepare the draft labeling and coordinate with the labeling vendors to revise the labeling as directed by the supervisor
• Proofs read the labeling upon receipt from the labeling vendor for accuracy, formatting and process the final labeling for review and approval internally within Qualitest and communicate the approvals to vendors.
• Responsible to organize and file labeling files/folders (both electronic and paper based) as per Qualitest procedures and policies.
• Maintain the log and status reports of labeling activities
• Prepare side by side comparison of proposed labeling against current approved labeling for submission to the FDA

Qualifications

Qualifications: Good writing skills, strong organizational skills; detail oriented; proficient in MS Word, Adobe Acrobat and document scanning program, printing; strong interpersonal skills and excellent working relationship for interacting with internal/external customers; skilled at multi-tasking and prioritizing the workload; ability to work well independently or within a group with minimal supervision; ability to work effectively in a deadline-driven environment. Ability to utilize creative abilities and current practices to solve issues within the scope of the responsibilities. Knowledge of FDA requirements and understanding of pharmaceutical labeling

Preferred: Technical competency in labeling

Required: BS degree (or 3 years of equivalent experience in Regulatory Affairs)