Regulatory Affairs Specialist

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 European and Global markets: preparation of CCDS, CTD, SmPC, and PIL.

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.

Regulatory Compliance:

• Continuously monitor and maintain up-to-date knowledge of 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.

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.

Experience

• 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 the European market.
• Proven experience in the lifecycle maintenance of medical products.
• Hands-on experience with Marketing Authorization Applications (MAA), Common Technical Documents (CTD), Company Core Data Sheet (CCDS), Patient Information Leaflet (PIL), and product labeling.
• 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 French with excellent communication skills—both written and verbal.
• 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.