Regulatory Compliance Change Assessor - Manager

India - Hyderabadmid

Legal & ComplianceCompliance

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Quick Summary

Key Responsibilities

Key responsibilities of the Regulatory Manager include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope.

Technical Tools

Legal & ComplianceCompliance

Regulatory

Let’s do this. Let’s change the world. In this vital role you will report into the Regulatory Compliance Team lead.

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level.

Responsibilities

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Key responsibilities of the Regulatory Manager include:

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Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope.
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Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system.
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Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies
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Provides expertise and guidance to interdepartmental and cross-functional teams
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Coaches and support junior regulatory staff’s career development
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Identifies and implements process improvements for the change management process

Requirements

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We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

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

Degree in Life Science discipline
Regulatory CMC specific knowledge & experience
Understanding and application of principles, concepts, theories and standards of scientific/technical field
Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Objects in your future are closer than they appear. Join us.