Alternance - Chargé(e) D'affaires Réglementaires H/f

Amgen Australia Pty Ltd

France
Not specified; not specified; generous global comp...
French language proficiency required
English reading and writing skills
Office software (pack office) usage
This role involves actively participating in registration activities, including reviewing and validating translations of SmPCs, labels, and notices for the French market

Job Summary

  • This role involves actively participating in registration activities, including reviewing and validating translations of SmPCs, labels, and notices for the French market.
  • The candidate will coordinate regulatory submissions for clinical studies and in vitro medical devices with the ANSM and international teams.
  • Amgen offers a supportive environment with daily mentorship, diverse career development opportunities, and a comprehensive benefits package focused on well-being.

Matching Summary

This role involves actively participating in registration activities, including reviewing and validating translations of SmPCs, labels, and notices for the French market.

Salary

Not specified; Not specified; Generous global compensation plan including health coverage and flexibility

Skills & Requirements

Must-have

  • French language proficiency required
  • English reading and writing skills
  • Office software (Pack Office) usage
  • Regulatory compliance knowledge
  • Clinical study documentation experience

Nice-to-have

  • Strong communication and synthesis skills
  • Proactive work attitude
  • Collaborative team spirit
  • Interest in biotech innovation
  • Ability to work autonomously

Key Requirements

  • Bac+6 degree in Pharmacy or Health Law
  • Alternance contract (apprenticeship)
  • Specialization in Regulatory Affairs or Health Law

Work Rights

Must have right to work in France for apprenticeship

Tailored Resume

Cover Letter