Regulatory Affairs Manager| Eli & South Africa

Amgen Inc

South Africa
Not specified; not specified; generous total rewar...
**
6 years regulatory experience in pharmaceutical industry
Bachelor's degree in pharmacy or relevant field
Knowledge of us fda and emea regulatory guidelines
** Amgen Inc. is seeking a Regulatory Affairs Manager for their operations in South Africa. The role involves ensuring compliance with regulatory requirements, building professional relationships with health authorities, and contributing to the regulatory strategy for new drug approvals. **

Job Summary

  • The role involves providing high-quality regulatory input for new marketing authorizations and line-extensions while maintaining established products.
  • Candidates must possess at least six years of regulatory experience within the pharmaceutical industry or with Health Authorities.
  • Amgen offers a diverse and inclusive community where teammates are empowered to bring ideas to the table and act on them.

Matching Summary

Match Score: 75

** Amgen Inc. is seeking a Regulatory Affairs Manager for their operations in South Africa. The role involves ensuring compliance with regulatory requirements, building professional relationships with health authorities, and contributing to the regulatory strategy for new drug approvals. **

Salary

Not specified; Not specified; Generous Total Rewards Plan comprising health, finance, work/life balance, and career benefits

Skills & Requirements

Must-have

  • 6 years regulatory experience in pharmaceutical industry
  • Bachelor's degree in Pharmacy or relevant field
  • Knowledge of US FDA and EMEA regulatory guidelines
  • People management and staff development skills
  • Ability to interpret scientific data for regulatory documents

Nice-to-have

  • Experience with global matrix organization collaboration
  • Strong analytical approach with attention to detail
  • Proven track record in audit facilitation and compliance
  • Excellent communication skills for cross-functional teams

Key Requirements

  • Minimum 6 years regulatory experience
  • Bachelor's degree in Pharmacy or related field
  • People management experience required
  • Understanding of US FDA and EMEA guidelines

Work Rights

Not specified

Tailored Resume

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