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Regulatory Affairs Specialist

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Product Life Group

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Location:
Romania

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Category:
Consulting

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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.

Job Responsibility:

  • 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
  • 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
  • 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
  • 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

Requirements:

  • 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
  • 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

Nice to have:

  • Experience in a consultancy and/or multi-client setting
  • Experience in promotional / non-promotional activities
  • Experience in people coordination or mentoring

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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