Associate – Regulatory Affairs
Location: Hyderabad, India
Job ID: R-218809
Posted On: July 1, 2025
Employment Type: Full-Time | On-Site
About Amgen:
Amgen is a global biotechnology innovator dedicated to discovering and delivering transformative therapies for serious illnesses. With over 40 years of industry leadership, we combine biological science with advanced technology to improve the lives of patients worldwide.
About the Role:
As an Associate – Regulatory Affairs, you will play a vital cross-functional role in supporting FDA 2253 promotional submissions, managing Amgen’s digital assets, and facilitating label change operations. This position demands a unique blend of regulatory knowledge, project coordination skills, and creative expertise with tools like Adobe Creative Suite and Veeva PromoMats. Your work will directly impact the regulatory integrity and marketing readiness of Amgen’s commercial assets.
Key Responsibilities:
Manage and release FDA Form 2253 submissions for marketed promotional materials.
Serve as Digital Asset Management (DAM) librarian, ensuring proper tagging, storage, and retrieval of creative assets.
Evaluate metadata and licensing details of submitted creative files, ensuring compliance and accuracy.
Collaborate with creative agencies to manage usage rights, asset renewals, and licensing documentation.
Support cross-functional regulatory initiatives such as label change processes, promotional reviews, and commercial readiness.
Coordinate and participate in stakeholder meetings, prepare agendas, and document meeting minutes.
Create infographics and editable assets using Adobe Creative Suite, while supporting technical editing and compliance documentation.
Maintain and troubleshoot content and workflows in Veeva PromoMats, RIM, SharePoint, and BOX.
Develop and maintain SOPs and workflow guides related to DAM and regulatory operations.
Use Veeva reporting tools to generate performance reports and support decision-making.
Required Skills & Experience:
Proficient in Veeva PromoMats, RIM, and SharePoint with hands-on experience in workflow navigation.
Knowledge of FDA guidance on promotional submissions and eCTD packaging.
Hands-on expertise with Adobe Creative Suite (Photoshop, Illustrator, InDesign, Premiere Pro, After Effects).
Familiarity with digital asset tagging, archiving, naming conventions, and compliance metadata standards.
Strong project coordination, multitasking ability, and attention to detail in high-pressure environments.
Excellent communication and stakeholder liaison skills.
Experience preparing 2253 packages using Veeva systems and knowledge of eCTD publishing tools.
Preferred Qualifications:
Bachelor’s degree in Graphic Design, Marketing, Visual Arts, or related field.
2+ years of experience in the pharmaceutical or healthcare marketing space.
Veeva Business Admin certification preferred.
Deep understanding of FDA regulations for promotional compliance.
Proven track record of liaising with creative agencies and internal cross-functional teams.
Strong reporting and documentation skills using Microsoft Office (Excel pivot tables, PowerPoint, Visio).
Working Hours:
Flexible shifts required to support US product launches and regulatory deadlines, including occasional overnight work.
Estimated Salary: ₹8–12 LPA (based on experience, role complexity, and industry benchmarks)
Gujarat :
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