Das ist der Job
Validate, maintain, and manage regulatory data for medicinal products in compliance with EMA guidelines.
Darum lohnt es sich
Collaborate with cross-functional teams to ensure compliance and timely regulatory submissions. Proficiency in Microsoft 365 tools (Excel, Teams, SharePoint).
Effective communication and teamwork abilities. #J-18808-Ljbffr Responsibilities Responsible for managing and maintaining regulatory data, supporting EMA submissions, and ensuring compliance with European regulatory requirements.
Hands-on experience with xEVMPD, Veeva Vault RIM, and lifecycle management activities across authorized and investigational medicinal products. Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements using Register/AgXchange, EV Web, and Veeva Vault.
Support Product Lifecycle Management (PLM) activities, including variations, renewals, and regulatory updates for CAPs and non-CAPs. Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) activities, ensuring timely and accurate submissions.
Prepare and manage EMA deliverables such as eAF (electronic Application Forms) and eSMP (electronic Summary of Product Characteristics). Handle submission and maintenance of regulatory documents including SmPC, PIL, and Health Authority communications.
Work on regulatory procedures such as xEVMPD, IDMP, CTA, MAA, and lifecycle management activities. Utilize Veeva Vault RIM for submissions, tracking, and regulatory data management. Ensure accurate data aggregation, mapping, and consistency across multiple regulatory systems and documents (RIMS, DMS).
Qualifications Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field. Proven experience in Regulatory Affairs with focus on EMA submissions and xEVMPD. Hands-on experience with Veeva Vault RIM and regulatory submission tools. Strong knowledge of EU regulatory processes (CTA, MAA, IDMP, lifecycle management).
Familiarity with regulatory systems such as RIMS and DMS. Strong analytical skills with ability to collect, interpret, and map complex data. High attention to detail and strong organizational skills.
