Regulatory Affairs Senior Associate
Location: Hyderabad, India
Job ID: R-219149
Posted On: July 1, 2025
Employment Type: Full-Time | On-Site
About Amgen:
Amgen is a global leader in biotechnology with over four decades of pioneering science and innovation to address some of the world’s most serious diseases. By integrating advanced genetic insights with cutting-edge technology, Amgen delivers transformative medicines to millions of patients.
About the Role:
As a Regulatory Affairs Senior Associate, you will support US Promotion Regulatory representatives by managing Ad/Promo regulatory data, label changes, and promotional material workflows across multiple product brands. You will ensure the regulatory integrity of promotional materials through accurate submissions, labeling updates, digital labeling oversight, and system maintenance. This cross-functional role plays a key part in supporting Amgen’s US Business Operations, especially in high-impact initiatives like product launches and ISI updates.
Key Responsibilities:
Manage and track label change updates, Important Safety Information (ISI) revisions, and promotional content implementation.
Coordinate Package Component Labeling (PCL) and logo changes; manage product imagery and Product Shot Index.
Oversee Ad/Promo FDA communication documentation: RFACs, Intent to Comply, ROC, PDMA, and DHCP letters.
Prepare label change content assessment binders and system workflow assessments for impacted promotional material.
Enter and retrieve structured data from Veeva PromoMats and RIM, ensuring regulatory record accuracy and archiving.
Support US digital labeling operations and maintain tracking metrics and savings for label implementation activities.
Author and edit regulatory process documentation; create visuals like infographics and slides for cross-functional communication.
Lead and minute MS Teams meetings, organize Outlook inbox tasks, and apply email automation rules.
Required Knowledge and Skills:
Experience using Veeva PromoMats to build eCTD compliance packages for FDA submissions.
Strong understanding of FDA promotional regulations and submission protocols.
Proficiency in Veeva RIM Vault, including record archiving and metadata management.
Working knowledge of MLR review process using Veeva PromoMats for Abbreviated Reviews.
Technical proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio); ability to use Excel pivot tables and formulas.
Familiarity with SharePoint and MS Teams for process documentation and collaboration.
Excellent editing, proofreading, and graphic/presentation design skills.
Preferred Qualifications:
Bachelor’s degree and 6+ years of experience in US Regulatory Ad/Promo or related field.
Prior experience at Amgen or in another biopharmaceutical company in regulatory advertising/promotions.
Veeva Business Admin certification (PromoMats & RIM).
Strong project management background, especially in regulatory labeling or promotional review environments.
Working Hours:
Flexible AIN working hours, including occasional overnight shifts to support US product launches or new indication rollouts.
Estimated Salary: ₹10–14 LPA (based on role complexity and experience level)
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