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Regulatory Compliance Change Assessor - Manager

10-12 years
Not Disclosed
10 Jan. 16, 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 - Manager - India - Hyderabad
The Regulatory Compliance Change Assessor will play a crucial role in interfacing with various teams, including the Amgen Global, Site, Biosimilars, and Device RA CMC teams, along with Amgen Operations, Quality, and/or Supply Chain. This position involves varying levels of product support, with a focus on assessing global reportability and cross-product changes, depending on the individual's experience level.

Roles & Responsibilities
Key responsibilities include:

  • Reviewing change records to evaluate the impact on product restrictions and reportability.
  • Defining and documenting reporting and product distribution restriction requirements within the change control management system.
  • Liaising with Process Development, Operations, Quality, and Supply Chain to ensure regulatory strategy alignment.
  • Providing expertise and guidance to interdepartmental and cross-functional teams.
  • Coaching junior regulatory staff and supporting their career development.
  • Identifying and implementing improvements in the change management process.

Basic Qualifications

  • Doctorate degree OR
  • Master's degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
  • Bachelor's degree and 6 to 8 years of experience in the same OR
  • Diploma and 10 to 12 years of experience in the same field.

Preferred Qualifications

  • Degree in Life Science discipline
  • Regulatory CMC knowledge and experience
  • Understanding of scientific/technical field principles, concepts, and standards
  • Experience in pharmaceutical/biotech industry manufacture, testing (QC/QA or clinical), or distribution.

What You Can Expect
Amgen offers a competitive benefits package, including Total Rewards Plans aligned with industry standards, along with career development opportunities in a collaborative environment.