Job Title: Senior Associate, Global Submission Management – International
Location: India – Hyderabad (On Site)
Job ID: R-206643
Date Posted: April 24, 2025
Category: Regulatory
Company: Amgen
Job Summary
Amgen is seeking a Senior Associate to manage regulatory submissions across international markets (excluding US and Canada). This role focuses on the planning, coordination, and technical compliance of submission content for clinical trials and marketing applications. Candidates should have strong expertise in Veeva Vault RIM, eCTD, and international regulatory requirements.
Key Responsibilities
Lead/support the creation and delivery of clinical trial and marketing application submissions
Manage Global/Submission Content Plans within Veeva Vault RIM
Collaborate with internal teams and external partners to ensure timely regulatory submission and archival
Interpret and operationalize regulatory guidance and requirements
Ensure compliance with submission standards (eCTD, NeeS, etc.) and Amgen SOPs
Contribute to strategy for communicating with international regulatory authorities
Drive continuous improvement in submission processes and tools
Participate in system validations and software updates
Represent submission function in global workstreams and projects
Required Knowledge and Skills
Expertise in eCTD/NeeS submissions (originals, amendments, periodic reports, etc.)
Advanced user of Veeva Vault RIM for planning and dashboard reporting
Experience with regulatory submission tools, preferably Lorenz docuBridge Explorer
Working knowledge of global and emerging market submission standards
Strong technical and project management skills
Preferred Knowledge and Skills
Familiarity with EU, JAPAC, GCC, and ZA regulatory submission requirements
Experience collaborating across departments (Regulatory Strategy, Safety, Clinical, CMC, Labeling, etc.)
Experience in cross-functional submission planning and project execution
Education & Experience Requirements
Master’s degree with 3–4 years of experience
OR Bachelor’s degree with 4–6 years
OR Associate’s degree with 6–8 years
OR High school diploma / GED with 8+ years of directly related experience
Why Join Amgen
Global impact in regulatory science
Opportunity to manage high-value projects across diverse geographies
Culture of innovation and continuous learning
How to Apply
Visit: careers.amgen.com
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