Senior Manager, Global Submission Management - Americas

14-18 years

Not Disclosed

Hyderabad

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 shape and execute the strategic framework for regulatory submissions across the Americas markets. By leading the Americas GSM team in AIN, collaborating with GSIM leadership, vendor partners, and cross-functional filing teams—including International Regulatory Affairs teams—you will optimize submission management, leveraging internal and external resources to drive accelerated filing execution within regional and multi-regional contexts.

Key Responsibilities

Leadership & Team Management

Manage and mentor a high-performing AIN team responsible for regulatory submission management to Americas markets.
Implement optimized resourcing strategies, utilizing internal teams and external partners for submission-related activities.

Operational Excellence

Drive process improvements for submission tools, methodologies, and workflows.
Develop and implement policies, SOPs, training materials, and guidelines for regulatory practices.
Ensure regulatory information and systems meet global compliance standards.

Innovation & Strategy

Champion innovation within submission processes to enhance efficiency and maintain industry leadership.
Identify opportunities to streamline processes and adopt new technologies to improve outcomes.

Compliance & Stakeholder Engagement

Ensure staff understanding and adherence to global and regional regulatory guidelines.
Build strong relationships with internal and external stakeholders, including regulatory authorities, to support submission goals.

Required Knowledge and Skills

Proven leadership in regulatory submission management to the US and regional 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 the ability to lead cross-functional teams.
Effective collaboration and communication skills with internal/external stakeholders and regulatory authorities.
Analytical and problem-solving skills to address complex regulatory and system challenges.

What We Expect of You

We value diversity and unique contributions in serving patients. The professional we seek is a visionary 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:

Extensive leadership in submission management of eCTD in the US, Canada, and submissions across Central and South America.
Advanced knowledge of global and regional regulatory requirements for submissions, including eCTD and related software.
Advanced expertise in regulatory publishing systems.
Experience in global regulatory submission delivery and managing large-scale enterprise systems in the Biotech/Pharmaceutical industry.
Strong experience in regulatory operations and submission management.

What You Can Expect from Us

At Amgen, we are committed to helping you grow both professionally and personally. We offer:

Competitive base salary and comprehensive Total Rewards Plans aligned with local industry standards.
A supportive and collaborative work culture that fosters innovation and career growth.

Apply Today
Take the next step toward a career that defies imagination. Join us at careers.amgen.com.

Amgen is an Equal Opportunity Employer
We welcome all qualified applicants and are committed to providing reasonable accommodations for individuals with disabilities during the application or interview process, as well as during employment. Please contact us to request accommodations.

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Senior Manager, Global Submission Management - Americas

Job Description

Key Responsibilities

Required Knowledge and Skills

What We Expect of You

Basic Qualifications:

Preferred Qualifications:

What You Can Expect from Us

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