Regulatory Compliance Change Assessor - Manager

10-12 years

Not Disclosed

Hyderabad

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

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Job Title: Regulatory Compliance Change Assessor - Manager
Location: India - Hyderabad
Job ID: R-203257
Date Posted: Jan. 15, 2025
Category: Regulatory
Work Location Type: On Site

Position Overview:
The Regulatory Compliance Change Assessor - Manager will report to the Regulatory Compliance Team lead and interact with Amgen Global teams, Site teams, Biosimilars, and/or Device RA CMC teams. The role focuses on ensuring regulatory compliance for product changes, providing global reportability assessments, and supporting cross-functional teams. Additionally, the Manager will guide and mentor junior staff and identify opportunities for improving the change management process.

Key Responsibilities:

Review change records to evaluate their impact on product reportability and restrictions.
Define and document reporting and product distribution restrictions within the change control management system.
Collaborate with functions like Process Development, Operations, Quality, and Supply Chain to align regulatory strategies.
Provide expertise and guidance to interdepartmental and cross-functional teams.
Coach and support the career development of junior regulatory staff.
Identify and implement process improvements for change management.

Qualifications:

Basic Qualifications:

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

Preferred Qualifications:

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

About the Role:
This managerial position combines regulatory expertise and leadership. The Regulatory Compliance Change Assessor Manager will ensure regulatory compliance across Amgen's products, guide junior staff, and drive continuous improvement in regulatory processes.

What You Can Expect:
Amgen offers a supportive environment for professional growth, along with competitive compensation and benefits, ensuring that you thrive in a collaborative culture while making impactful contributions to the field of healthcare.

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Regulatory Compliance Change Assessor - Manager

Job Description

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