Responsibilities

1. Submission & Registration Activities

  • Prepare, compile, and submit Marketing Authorisation Applications (MAA), including new MAAs and variations, for Germany and assigned EU countries.
  • Support Orphan Drugs, line extensions, and launch readiness activities.
  • Contribute to registration strategies and timelines in collaboration with PLG project teams and clients.

2. Product Lifecycle Management

  • Manage post‑approval activities, including:
    • Variations
    • Renewals
    • Product Information (SmPC, PIL, Labelling)
    • Artwork review and updates
  • Ensure compliance with approved documentation throughout the lifecycle of assigned products.

3. Regulatory Compliance & Quality

  • Monitor and maintain up‑to‑date knowledge of national (Germany) and European regulatory requirements and legislation.
  • Ensure full compliance with:
    • Regulatory processes
    • Assigned country regulations
    • Client‑specific procedures
  • Ensure readiness for internal and external audits.
  • Effectively manage Non‑Conformities (NCs) and CAPAs in a timely manner.

4. Health Authority Interaction & Communication

  • Act as a key contact with Health Authorities, ensuring effective and professional communication.
  • Support and respond to internal and client regulatory queries.
  • Collaborate with cross‑functional teams in a multi‑client consultancy environment.

5. Systems, Tools & Data Management

  • Use regulatory and document management systems to:
    • Prepare correspondence and submissions
    • Track regulatory activities and timelines
    • Maintain databases and documentation
  • Regularly work with tools such as:
    • Microsoft Office Suite
    • Veeva Vault or comparable EDMS
    • LorenZ
    • TrackWise
    • PromoMats
  • Ensure accurate time and task tracking across assigned activities.

Experience

  • Degree in a relevant life science discipline (Pharmacy, Biology, Chemistry, or similar)
  • 2-5 years of relevant Regulatory Affairs experience
  • Strong experience in German Regulatory Affairs
  • Proven experience across Product Lifecycle Management, including:
  • New MAAs
  • Variations
  • Orphan Drugs
  • Line extensions
  • Product Information updates
  • Artwork review
  • Experience interacting with Health Authorities
  • Experience working in a consultancy and/or multi‑client setting is an advantage
  • Good IT and digital tool proficiency
  • Excellent organizational and communication skills
  • Pro‑active mindset with the ability to work autonomously and in teams
  • Willingness to take ownership and responsibility
  • Ability to manage multiple priorities and workloads
  • Experience in promotional / non‑promotional activities is a plus
  • Experience in people coordination or mentoring is an advantage

Publish Date

01 July, 2026

Spontaneous Application

Regulatory Affairs Specialist (Germany) - VAF 585

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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