Regulatory Compliance Change Assessor - Sr Associate

Amgen Inc.

3.6

(9)

Hyderabad, India

Why you should apply for a job to Amgen Inc.:

67% say women are treated fairly and equally to men

78% would recommend this company to other women

Ratings are based on anonymous reviews by Fairygodboss members.

Flexible work models that empower staff members to work where and when they are most productive

Award-winning PTO plan and bi-annual company-wide shutdowns

With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging

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Position summary

Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies

What we expect of you

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

Basic Qualifications:

Master's degree OR
Bachelor's degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
Associate's degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

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