PLG is seeking a motivated and detail‑oriented Regulatory Affairs Specialist to join our Regulatory Affairs team as a maternity cover.
In this role, you will be responsible for Regulatory Affairs activities primarily for Romania, with exposure to other EU markets, ensuring compliance throughout the full product lifecycle, from registration to post‑approval maintenance.

Responsibilities:

1. Submission & Registration Activities

  • Prepare, compile, and submit Marketing Authorisation Applications (MAA), including new MAAs and variations, for Romania 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 (Romanian) 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)
  • Minimum 5 years of relevant Regulatory Affairs experience
  • Strong experience in Romanian 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
    • 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

Regulatory Affairs Specialist (Romania)

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