Regulatory Affairs And Medical Compliance Assistant (m/w/d)

AstraZeneca

Base: €46,768.80; bonus/equity: depending on compy...
Hybrid
Regulatory sharepoint super user
Prepare fachinformation, gebrauchsinformation
Handle parallel imported products
Supports the regulatory team in all activities related to the registration and maintenance of products, as well in GRP (Good Regulatory Practice), in compliance with all local and global codes, standards and procedures

Job Summary

  • Supports the regulatory team in all activities related to the registration and maintenance of products, as well in GRP (Good Regulatory Practice), in compliance with all local and global codes, standards and procedures.
  • Oversees, organises and manages the Regulatory Affairs digital and hardcopy archive, ensuring appropriate archiving according to the retention guideline (acts as the RA team Archive Coordinator).
  • Base salary: €46,768.80 per year (full-time basis) with bonus opportunities and comprehensive social benefits.

Matching Summary

Supports the regulatory team in all activities related to the registration and maintenance of products, as well in GRP (Good Regulatory Practice), in compliance with all local and global codes, standards and procedures.

Salary

Base: €46,768.80; Bonus/Equity: depending on company performance; Benefits: Comprehensive social benefits, company pension scheme, supplementary insurance

Skills & Requirements

Must-have

  • Regulatory Sharepoint super user
  • Prepare Fachinformation, Gebrauchsinformation
  • Handle parallel imported products
  • RA SOP and BCP maintenance
  • RA digital and hardcopy archive management
  • Quality assurance and business compliance support

Nice-to-have

  • Agile thinking and pragmatic approach
  • Efficient, meticulous, self-motivated
  • Innovative and creative ideas
  • Strong interpersonal and team interaction skills
  • Environmentally conscious company

Key Requirements

  • At least 3 years' professional experience
  • Command in English and German
  • Matura/ Abitur or equivalent education
  • Proficient MS Office

Work Rights

Not specified

Tailored Resume

Cover Letter