Senior Regulatory Affairs Associate

Parexel

Senior Regulatory Affairs Associate managing regulatory data and supporting EMA submissions at Parexel. Ensuring compliance with European regulatory requirements in a global clinical research organization.

Posted 6/19/2026full-timeRemote • 🇮🇳 IndiaSeniorWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

xEVMPDregulatory data managementProduct Lifecycle Management (PLM)Post-Marketing Surveillance (PMS)electronic Application Forms (eAF)electronic Summary of Product Characteristics (eSMP)data aggregationdata mappingregulatory submissionsregulatory compliance

Soft Skills

analytical skillsattention to detailorganizational skillscommunication abilitiesteamwork