Senior Regulatory Affairs Associate

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.
• Validate, maintain, and manage regulatory data for medicinal products in compliance with EMA guidelines.
• 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).
• Collaborate with cross-functional teams to ensure compliance and timely regulatory submissions.

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.
• Proficiency in Microsoft 365 tools (Excel, Teams, SharePoint).
• Strong analytical skills with ability to collect, interpret, and map complex data.
• High attention to detail and strong organizational skills.
• Effective communication and teamwork abilities.