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