Job Title: Senior Associate, Global Submission Management – International
Location: India – Hyderabad (On Site)
Job ID: R-206629
Date Posted: April 11, 2025
Category: Regulatory
Company: Amgen
Job Summary
Amgen is seeking a Senior Associate, Global Submission Management – International to ensure the smooth flow of regulatory submissions across global markets. The role will lead and support the creation, planning, and delivery of regulatory submission components, leveraging technical expertise to ensure compliance with global regulatory requirements. This position will require a strong background in international submission management and regulatory submissions.
Key Responsibilities
Lead and support various Clinical Trial and Marketing Application type submissions
Manage the creation, maintenance, and management of Global/Submission Content Plans
Serve as the point of contact between internal and external stakeholders for regulatory submissions
Ensure smooth delivery and archiving of regulatory documents in Veeva Vault RIM
Stay current on internal and external regulatory guidance, translating requirements into operational tasks
Represent departmental expertise in global/regional workstreams and regulatory projects
Contribute to the development of strategies for communicating with global health authorities
Lead and manage process development and improvement initiatives
Participate in information system updates and ongoing system validations
Required Skills and Experience
Master’s degree and 3-4 years or Bachelor’s degree and 4-6 years of directly related experience in regulatory submission management
Experience with eCTD format, NeeS, and paper submissions
Advanced knowledge of Veeva Vault RIM and the management of submission content plans, reports, and dashboards
Strong project management skills and experience working across multiple disciplines (e.g., Clinical, Safety, CMC, Regulatory Strategy)
Practical experience with submission requirements for EU, JAPAC, GCC, and ZA regions
Preferred Skills
Advanced knowledge of eCTD specifications and software (e.g., Lorenz docuBridge Explorer)
Expertise in global Clinical Trial and Marketing Applications regulations and guidance
Strong team leadership and coordination skills
Experience with system validation and information system updates
Why Join Amgen
Be part of a collaborative and innovative environment dedicated to serving patients
Competitive benefits and career growth opportunities
Work on impactful global regulatory projects
How to Apply
Visit: careers.amgen.com
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