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Manage and maintain regulatory data for medicinal products while supporting EMA submissions and ensuring compliance with European requirements. Handle lifecycle management activities, including variations, renewals, and the preparation of EMA deliverables like eAF and eSMP.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.
- 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.
Required Skills & 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.
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