Senior Regulatory Affairs Associate

Parexel International (india) Private Limited

Hyderabad

Not disclosed

Work from Office

Full Time

Min. 5 years

Job Details

Job Description

Senior Regulatory Affairs Associate

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.

Experience Level

Senior Level

Job role

Work location

India-Hyderabad-Remote

Department

Healthcare / Doctor / Hospital Staff

Role / Category

Nurse / Patient Care / Hospital Staff

Employment type

Full Time

Shift

Day Shift

Job requirements

Experience

Min. 5 years

About company

Name

Parexel International (india) Private Limited

Job posted by Parexel International (india) Private Limited

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