Regulatory Affairs Specialist

Overview PLG is seeking a motivated and detail-oriented Regulatory Affairs Specialist to join our growing life sciences company. In this role, you will ensure global compliance with regulatory requirements throughout the product lifecycle, from development and approval to post-market maintenance. Responsibilities 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 Polish and global markets. Support Technical/Site Transfer Applications for product launches and changes. 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, Line extensions, Product Information, Artwork, and ensure compliance with approved documentation. Regulatory Compliance: Continuously monitor and maintain up-to-date knowledge of national, European, and international regulatory guidelines and legislation. Ensure strict compliance with regulatory requirements and readiness for both internal and external audits. Communication: Serve as a key liaison between our company and regulatory authorities, facilitating clear communication and timely submissions. Respond to internal inquiries and provide regulatory support to cross-functional teams. 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. Experience & Qualifications Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree or higher is a plus). 5-10 years of relevant experience in Regulatory Affairs, focusing on Polish markets. Proven experience in the lifecycle maintenance of medical products. Hands-on experience with Marketing Authorization Applications (MAA), Common Technical Documents (CTD), product labeling, Orphan Drugs, Line extensions, Product Information updates, Artwork review. Strong familiarity with European Regulatory Authorities and international 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 and Polish, 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. Experience in people management or coordination is a plus. Previous experience in promotional/non-promotional activities is an advantage. #J-18808-Ljbffr