Senior Regulatory Compliance Specialist

1 day ago

Hyderabad, Telangana, India beBeeRegulatory Full time US$ 80,000 - US$ 1,50,000
Job Title: Regulatory Affairs Senior Associate

As a senior associate in regulatory affairs, you will play a critical role in ensuring compliance with regulatory strategies for department initiatives.

This position is responsible for assisting in preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials.

Key responsibilities include managing all Ad Promo regulated data management, including label change updates and implementation process, logo, package component labeling (PCL) changes, and important safety information (ISI) updates.

Additionally, you will track team performance and savings for label change implementation, manage digital labeling, and perform system workflow assessments of label-impacted promotional material.

Archive regulatory information management (RIM) documents, submit Request for Advisory Comments (RFAC) submissions, and report on Ad Promo FDA communications.

Requirements
  • Masters degree and 4 years related experience, or Bachelor's degree and 6 years related experience.
  • Experience working in a Global Regulatory Affairs organization and knowledge of FDA promotional regulations.
  • Technical skills in Veeva, MS Office, and SharePoint.
Why this role?

This role offers the opportunity to work in a fast-paced environment, utilizing your technical skills to drive business results. You will have the chance to develop your expertise in regulatory affairs, while contributing to the success of our organization.

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