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

Job Title: Regulatory Compliance Change Assessor - Manager
Location: India - Hyderabad
Job ID: R-203260
Date Posted: Jan. 15, 2025
Category: Regulatory
Work Location Type: On Site

Position Overview:
In this pivotal role, the Regulatory Compliance Change Assessor will report to the Regulatory Compliance Team lead and collaborate with Amgen Global teams, Site teams, Biosimilars, and/or Device RA CMC teams. The role involves providing strategic regulatory support, assessing the impact of product changes, and ensuring alignment across cross-functional teams. The Manager will also lead, mentor, and guide junior staff, while identifying opportunities for process improvements.

Key Responsibilities:

Review change records to assess their impact on product reportability and restrictions.
Define and document reporting and product distribution restrictions within the change control management system.
Liaise with other functions such as Process Development, Operations, Quality, and Supply Chain to align regulatory strategies.
Provide expertise and guidance to cross-functional teams to ensure regulatory compliance.
Mentor and support the career development of junior regulatory staff.
Identify and implement process improvements in the change management process.

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 is a leadership role that blends regulatory expertise with team management. The Regulatory Compliance Change Assessor Manager will ensure smooth regulatory processes for Amgen's products, mentor junior staff, and contribute to continuous improvement in regulatory strategies and processes.

What You Can Expect: Amgen supports your professional growth, offering competitive compensation and benefits while fostering a collaborative culture.

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Regulatory Compliance Change Assessor - Manager

Job Description

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