Not specified; not specified; generous total rewar...
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6 years regulatory experience in pharmaceutical industry
Knowledge of us fda and emea regulatory guidelines
People management and staff development skills
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Amgen UK is seeking a Regulatory Affairs Manager for its South Africa location, focusing on ensuring high-quality regulatory submissions and maintaining compliance for established products. The ideal candidate will have a strong background in regulatory affairs within the pharmaceutical industry, excellent communication skills, and a history of effective people management.
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Job Summary
The role involves providing high-quality regulatory input for new marketing authorizations and line-extensions while maintaining established products.
Candidates must have a bachelor's degree and at least six years of regulatory experience within the pharmaceutical industry or with Health Authorities.
Amgen offers vast opportunities for professional growth, a diverse inclusive community, and a generous total rewards plan including health and work/life balance benefits.
Matching Summary
Match Score: 75
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Amgen UK is seeking a Regulatory Affairs Manager for its South Africa location, focusing on ensuring high-quality regulatory submissions and maintaining compliance for established products. The ideal candidate will have a strong background in regulatory affairs within the pharmaceutical industry, excellent communication skills, and a history of effective people management.
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Salary
Not specified; Not specified; Generous Total Rewards Plan comprising health, finance, and career benefits
Skills & Requirements
Must-have
6 years regulatory experience in pharmaceutical industry
Knowledge of US FDA and EMEA regulatory guidelines
People management and staff development skills
Ability to interpret scientific data for filings
Experience maintaining regulatory databases
Nice-to-have
Strong communication skills in matrix setup
Analytical approach with attention to detail
Monitoring future regulatory trends
Building professional relationships with Health Authorities
Key Requirements
Bachelor's degree in Pharmacy or relevant field
Minimum 6 years of regulatory experience
People management experience is critical
Advanced ability to construct persuasive regulatory documents