PLG is seeking a motivated and detail-oriented Regulatory Affairs Officer to join our growing life sciences company. In this role, you will ensure European and local (Hungary) compliance with regulatory requirements throughout the product lifecycle, from development and approval to post-market maintenance.

Group 10
Responsibilities

Regulatory Affairs:

1. Submission and Approval Process:

  • Prepare and submit Manufacturing License Applications (MLA) for new products and site transfers.
  • Lead the preparation and submission of Marketing Authorization Applications (MAA) across Europe and Hungary.
  • Support Technical/Site Transfer Applications for product launches and changes.

2. Lifecycle Maintenance:

  • Manage post-approval regulatory processes, including Variations, Renewals, and Marketing Authorization Holder (MAH) Transfers/Certificates of Analysis (COA).
  • Handle updates to product labeling and ensure compliance with approved documentation.

3. Regulatory Compliance:

  • Continuously monitor and maintain up-to-date knowledge of European and Hungarian regulatory guidelines and legislation.
  • Ensure strict compliance with regulatory requirements and readiness for both internal and external audits.

4. Communication:

  • Serve as a key liaison between our company, client, and regulatory authorities, facilitating clear communication and timely submissions.
  • Respond to internal inquiries and provide regulatory support to cross-functional teams.

5. Software Utilization & Data Management:

  • Use a variety of software packages to create correspondence, prepare documents, maintain spreadsheets, and manage databases (e.g., Microsoft Office Suite, Veeva Vault or comparable EDMS, LorenZ, Trackwise, PromoMat).
  • Efficiently locate and extract information and data needed for regulatory submissions and lifecycle maintenance.
Pharmacovigilance:
  • Serve as the local point of contact for regulatory authorities.
  • Notify authorities of appointments and stay updated on local regulations.
  • Support PV activities led by the Medical Information & Vigilance Pillar/Hub.
  • Create and maintain local PV systems, including SOPs and agreements.
  • Handle safety case management: receipt, translation, tracking, and follow-ups.
  • Report ICSRs to local authorities (non-EU).
  • Conduct local literature and journal reviews.
  • Provide or support medical information services.
  • Assist in preparing client documents, reports, and tracking tools.
  • Coordinate with clients, affiliates, and third-party vendors

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Experience

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree or higher is a plus).
  • 3-5 years of relevant experience in Regulatory Affairs, focusing on Europe and Hungary.
  • Proven experience in the lifecycle maintenance of medical products.
  • Hands-on experience with Marketing Authorization Applications (MAA), Common Technical Documents (CTD), and product labeling.
  • Strong familiarity with European Regulatory Authorities and Hungarian regulatory frameworks.
  • Proficiency in regulatory software packages and databases, such as Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat, etc.
  • Fluent in English, with excellent communication skills—both written and verbal, proficiency in additional languages is a plus.
  • Excellent organizational skills with the ability to prioritize tasks and deliver high-quality work in a fast-paced environment.

Regulatory Affairs Officer - VAF139

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