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Parexel Senior Regulatory Affairs Associate Recruitment 2026: Apply Online
Senior Regulatory Affairs Associate
Job Overview
Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
- 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.
Key Job Details
| Company Name | Parexel |
| Job Role | Senior Regulatory Affairs Associate |
| Experience | Proven experience in Regulatory Affairs with focus on EMA submissions and xEVMPD. Hands-on experience with Veeva Vault RIM and regulatory submission tools. |
| Salary Range | |
| Job Type | Private |
| Work Mode | Remote |
| Openings | |
| Job Location | India – Hyderabad (Remote) |
Key Responsibilities
- 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 & 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.
Required Skills
- Regulatory Affairs
- EMA Guidelines
- xEVMPD Submissions
- Veeva Vault RIM
- Product Lifecycle Management (PLM)
- Post-Marketing Surveillance (PMS)
- eAF and eSMP preparation
- IDMP, CTA, MAA
- Data Management
- Data Aggregation and Mapping
- RIMS and DMS
- Microsoft 365 (Excel, Teams, SharePoint)
- Analytical Skills
- Attention to Detail
- Organizational Skills
- Communication Skills
- Teamwork
About Parexel
Parexel Consulting helps biopharmaceutical and medical device companies navigate the complex regulatory landscape. They value collaboration, innovation, and continuous learning, offering diverse client exposure and mentorship. The company provides remote work flexibility and fosters a supportive, dynamic team environment.
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