Job Title: Senior Associate, Global Submission Management – Americas
Location: India – Hyderabad (On Site)
Job ID: R-206638
Date Posted: April 7, 2025
Category: Safety
Company: Amgen
Job Summary
Amgen is seeking a Senior Associate to manage and coordinate regulatory submissions for the Americas (US, Canada, South America). This role ensures regulatory compliance, leads submission planning and dossier preparation, manages communications across internal and external teams, and maintains systems such as Veeva Vault RIM and eCTD tools. The role requires strong regulatory operations experience, project management skills, and technical proficiency in submission platforms and global regulations.
Key Responsibilities
Lead/support Clinical Trial and Marketing Application submissions and content plans
Coordinate cross-functional teams and external partners for timely submissions
Ensure compliance with global and local regulatory submission formats (eCTD, NeeS, paper)
Oversee submission archiving using Veeva Vault RIM
Contribute to strategy for global health authority communications
Lead or support process improvements and system validation projects
Monitor evolving regulatory guidance and translate into operations
Participate in updates and validations of regulatory information systems
Required Knowledge & Skills
Advanced knowledge of eCTD, NeeS, and paper submission formats
Expertise in Veeva Vault RIM: content plans, dashboards, maintenance
Experience with regulatory publishing tools (e.g., Lorenz docuBridge)
Familiarity with submission requirements for global markets
Ability to manage submission lifecycles and regulatory timelines
Strong project leadership and cross-functional collaboration skills
Preferred Qualifications
Practical submission experience for US, Canada, and South America
Advanced understanding of global regulatory frameworks
Knowledge of Clinical Trial and Marketing Application regulations
Strong communication and innovation mindset
Education Requirements
Master’s degree with 3–4 years of experience
Bachelor’s degree with 4–6 years of experience
Associate’s degree with 6–8 years of experience
High school diploma / GED with 8+ years of experience
Why Join Amgen
Impact global health through regulatory excellence
Work with cutting-edge tools and collaborative global teams
Benefit from comprehensive rewards and professional growth opportunities
How to Apply
Visit: careers.amgen.com
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