Regulatory Data & Systems Manager

8+ years

Not Disclosed

Hyderabad

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Regulatory Data & Systems Manager
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Jan. 10, 2025
Job ID: R-204065

Job Description

The Regulatory Data & Systems Manager will oversee system administration tasks and interpret requirements aligned with industry best practices and Amgen's regulatory processes. This role focuses on managing and optimizing systems, ensuring regulatory compliance, and facilitating seamless communication across departments involved in regulatory submissions.

Roles & Responsibilities

System Administration: Manage and maintain IT systems to ensure security, efficiency, and regulatory compliance.
Regulatory Business Analysis: Interpret and implement regulatory requirements adhering to industry standards.
Project Coordination: Plan, track, and execute departmental initiatives effectively.
Stakeholder Communication: Collaborate with internal and external stakeholders for timely updates and regulatory compliance.

Required Knowledge and Skills

Strong interpersonal skills with the ability to collaborate across diverse teams.
5+ years’ experience as a business analyst with proficiency in SDLC, Agile methodologies, and business analysis tools.
Effective oral and written communication skills for persuasive presentations.
Ability to thrive in a matrix environment while working independently.
Familiarity with GxP requirements and system validation processes.
Preferred experience in the Life Sciences, Biotech, or Pharmaceutical sectors.
Proven expertise in Veeva Vault systems.

Preferred Knowledge and Skills

Advanced Veeva Vault knowledge.
Familiarity with global regulatory processes and standards.
Proficiency in Agile methodologies such as Scrum or Kanban for enhanced collaboration.

Basic Education and Experience

Bachelor’s degree with 2 years of directly related experience.
Associate’s degree with 6 years of directly related experience.
High school diploma/GED with 8 years of directly related experience.

Preferred Education and Experience

Hands-on experience with regulatory data standards like IDMP.
5+ years’ experience administering large-scale enterprise systems in Biotech/Pharma industries.

Apply Now

Join Amgen and contribute to advancing science to serve patients, while enhancing your career in a dynamic, collaborative environment.

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Regulatory Data & Systems Manager

Job Description

Job Description

Roles & Responsibilities

Required Knowledge and Skills

Preferred Knowledge and Skills

Basic Education and Experience

Preferred Education and Experience

Apply Now

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