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Regulatory Compliance Change Assessor - Sr Associatea

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 Compliance Change Assessor - Sr Associate
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Jan. 10, 2025
Job ID: R-203263


Job Category: Regulatory


Job Description

The Regulatory Compliance Change Assessor - Sr Associate will collaborate with Amgen's Global, Site, Biosimilars, and Device RA CMC teams, as well as Operations, Quality, and Supply Chain, to evaluate strategies or activities impacting products. This role entails assessing and documenting the reportability of single or cross-product changes while ensuring alignment with regulatory requirements and organizational objectives.


Roles & Responsibilities

  • Change Record Review: Evaluate the impact of changes on reportability and product restrictions for products in scope.
  • Documentation: Define and document reporting and product distribution restriction requirements within the change control management system.
  • Collaboration: Liaise with Process Development, Operations, Quality, and Supply Chain teams to align regulatory strategies.

Qualifications

Basic Qualifications:

  • Master’s degree OR
  • Bachelor’s degree and 2 years of experience in manufacturing, QA/QC, or regulatory CMC within the Pharmaceutical/Biotechnology industry OR
  • Associate’s degree and 6 years of related experience OR
  • Diploma and 8 years of related experience.

Preferred Qualifications:

  • Degree in a Life Science discipline.
  • Regulatory CMC-specific knowledge and experience.
  • Understanding and application of principles, concepts, theories, and standards within the scientific/technical field.
  • Experience in manufacturing, testing (QC/QA or clinical), or distribution within the Pharmaceutical/Biotech industry.

Key Competencies

  • Strong analytical skills for assessing the impact of changes.
  • Effective communication and collaboration abilities to work across diverse teams.
  • Proficiency in regulatory compliance and change management systems.