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Regulatory Compliance Change Assessor - Sr Associate

2-7 years

Hyderabad / Secunderabad

Regulatory Compliance Change Assessor - Sr Associate

Amgen

posted 12hr ago

Job Role Insights

Flexible timing

Job Description

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.



Roles & Responsibilities:

Key responsibilities of the Regulatory Sr Associate include:

  • Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope.
  • Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system.
  • 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:

  • Masters degree OR
  • Bachelors degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
  • Associates 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

Employment Type: Full Time, Permanent

Read full job description

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What people at Amgen are saying

Senior Associate salary at Amgen

reported by 11 employees with 4-12 years exp.
₹8.5 L/yr - ₹25 L/yr
76% more than the average Senior Associate Salary in India
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What Amgen employees are saying about work life

based on 5 employees
75%
67%
67%
100%
Flexible timing
Monday to Friday
International travel
Day Shift
View more insights

Amgen Benefits

Submitted by Company
Health Insurance
Child care
Education Assistance
Employee volunteer program and company matching donation program
Flexible work environment
Competitive base pay and annual bonus opportunities
Submitted by Employees
Health Insurance
International Relocation
Child care
Gymnasium
Cafeteria
Work From Home +6 more
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