Regulatory Compliance Change Assessor - Manager

Amgen Technology Private Limited

4 - 12 years

5 - 15 Lacs

Hyderabad Telangana India

Posted:1 week ago| Platform: Foundit logo

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Skills Required

Regulatory Compliance Process Improvement Change Assessment Strategic Management Manufacturing Leadership

Work Mode

On-site

Job Type

Full Time

Job Description

Regulatory Compliance Change Assessor

Roles & Responsibilities

Change Assessment:
Review change records to evaluate the impact of changes with respect to reportability and product restrictions. You will define and document the reporting and product distribution restriction requirements within the change control management system.
Strategic Alignment:
Liaise with various functions, including Process Development, Operations, Quality, and Supply Chain, to ensure alignment of regulatory strategies. You will provide expertise and guidance to interdepartmental and cross-functional teams.
Leadership & Mentorship:
Coach and support junior regulatory staff in their career development.
Process Improvement:
Identify and implement process improvements for the change management process.

Technical Skills

Strong regulatory
CMC
specific knowledge and experience.
Understanding and application of principles, concepts, and standards in a scientific or technical field.
Experience in manufacture, testing (
QC/QA
or clinical), or distribution within the pharmaceutical or biotech industry.

Qualifications

A Doctorate degree, a Master's degree with relevant experience, a Bachelor's degree with extensive experience, or a Diploma with a substantial background in manufacturing,
QA/QC
, or regulatory
CMC
in the pharmaceutical/biotechnology industry.
A degree in a Life Science discipline is preferred.

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