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Regulatory Data & Systems Manager

8+ years
Not Disclosed
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
Posted: Jan. 10, 2025

Job Description
The Regulatory Data & Systems Manager will oversee system administration tasks and ensure alignment with regulatory requirements and Amgen processes. This role involves optimizing complex systems, maintaining compliance with industry regulations, and fostering collaboration among departments involved in regulatory submissions.

Roles & Responsibilities

  • System Administration: Manage IT systems to ensure security, efficiency, and regulatory compliance.
  • Regulatory Business Analysis: Interpret and implement regulatory requirements while adhering to industry best practices.
  • Project Coordination: Plan, track, and execute departmental projects and initiatives.
  • Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely communication of regulatory requirements and system updates.

Required Knowledge and Skills

  • Strong interpersonal and teamwork skills for effective collaboration across diverse teams.
  • 5+ years’ experience as a business analyst, with expertise in SDLC, Agile methodologies, and business analysis techniques.
  • Proficient in communication, capable of presenting ideas persuasively.
  • Familiarity with GxP requirements and systems validation.
  • Experience in the Life Sciences, Biotech, or Pharmaceutical industries.
  • Proven knowledge of Veeva Vault.

Preferred Knowledge and Skills

  • Advanced expertise in Veeva Vault.
  • Understanding of global regulatory processes and standards.
  • Proficiency in Agile methodologies, such as Scrum or Kanban, to enhance collaboration and efficiency.

Basic Education and Experience

  • Bachelor’s degree and 2 years of directly related experience OR
  • Associate’s degree and 6 years of directly related experience OR
  • High school diploma/GED and 8 years of directly related experience

Preferred Education and Experience

  • Practical experience with regulatory data standards, such as IDMP.
  • 5+ years’ experience administering large-scale enterprise systems in the Biotech/Pharmaceutical industry.

Apply Now
Join Amgen to advance science and serve patients, while growing your career within a collaborative and innovative culture.