Senior Regulatory Affairs Associate

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company 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, reputed company 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. reputed company xEVMPD submissions reputed company EMA Gateway and monitor acknowledgements using Register/AgXchange, EV Web, and reputed company 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 reputed company 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 reputed company field. Proven experience in Regulatory Affairs with focus on EMA submissions and xEVMPD. Hands-on experience with reputed company 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 reputed company 365 tools (reputed company, Teams, SharePoint). Strong analytical skills with ability to collect, interpret, and map reputed company data. High attention to detail and strong organizational skills. Effective communication and teamwork abilities. Apply To This Job