Regulatory Affairs Specialist

PLG is seeking a motivated and detail‑oriented Regulatory Affairs Specialist to join our Regulatory Affairs team. In this role, you will be responsible for Regulatory Affairs activities primarily for Germany, 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 Germany 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 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 (Germany) 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) 2-5 years of relevant Regulatory Affairs experience Strong experience in German Regulatory Affairs Proven experience across Product Lifecycle Management, including: New MAAs Variations Orphan Drugs Line extensions Artwork review Experience interacting with Health Authorities Experience working in a consultancy and/or multi‑client setting is an advantage Good IT and digital tool proficiency 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 #J-18808-Ljbffr