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Senior Manager, Global Submission Management - International

14-18 years
Not Disclosed
10 Dec. 3, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Let’s Do This. Let’s Change the World.

In this vital role, you will play a key part in shaping and executing the strategic framework for regulatory submissions across International (ex-Americas) markets. You will lead the International GSM team in AIN, collaborating with GSIM leadership, vendor partners, and cross-functional filing teams—particularly International Regulatory Affairs teams. Utilizing both internal and external resources, you’ll drive optimized submission management and accelerate filing execution within a regional and multi-regional context.


Key Responsibilities

  • Manage and mentor a successful AIN team responsible for regulatory submission management across International markets.
  • Implement optimized resource strategies, leveraging internal teams and external partners for submission-related activities.
  • Drive process improvements for submission tools, methodologies, and workflows.
  • Ensure staff adherence to global and regional regulatory guidelines.
  • Ensure regulatory information and systems meet global compliance standards.
  • Develop and implement policies, SOPs, training materials, and guidelines for regulatory practices.
  • Champion innovation within submission processes to enhance efficiency and maintain industry leadership.

What We Expect of You

We value diverse perspectives and unique contributions to serving patients. The professional we seek is an experienced and resourceful leader with the following qualifications:

Basic Qualifications

  • Doctorate degree and 2+ years of regulatory submissions or systems experience OR
  • Master’s degree and 8–10 years of regulatory submissions or systems experience OR
  • Bachelor’s degree and 10–14 years of regulatory submissions or systems experience OR
  • Diploma and 14–18 years of regulatory submissions or systems experience.

Preferred Qualifications

  • Proven leadership in regulatory submission management across global markets.
  • Advanced knowledge of regional regulatory requirements for clinical trial applications, marketing authorizations, and associated submissions, including eCTD and related software.
  • Expertise in regulatory information management systems (RIMS) and publishing solutions.
  • Strong project/program management skills, with experience managing cross-functional teams.
  • Effective collaboration and communication skills with internal/external stakeholders and regulatory authorities.
  • Analytical and problem-solving abilities to address complex regulatory and systems challenges.
  • Proven expertise in submission management of eCTD in regions such as Japan, China, Australia, EAEU, EU, MENA, and South Africa.
  • Experience with global regulatory submission delivery and large-scale enterprise systems in the Biotech/Pharmaceutical industry.
  • A background in regulatory operations and submission management.

What You Can Expect from Us

At Amgen, we are dedicated to helping you grow professionally and personally. With competitive benefits, a collaborative culture, and a commitment to innovation, we’re here to support your success.

In addition to a competitive base salary, Amgen offers comprehensive Total Rewards Plans tailored to local industry standards.


Apply Today
Take the next step toward a career that defies imagination. Visit careers.amgen.com to learn more and apply.


Amgen is an Equal Opportunity Employer
We welcome all qualified applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other protected categories.

If you require accommodations to participate in the application or interview process, perform essential job functions, or access other employment benefits, please contact us.