Parexel Careers Announces Regulatory Affairs Job for Pharma Professionals
Looking for a Regulatory Affairs Job with a leading global clinical research organization? Parexel Careers is hiring a Senior Regulatory Affairs Associate for its remote India team with an additional location in Bengaluru. This excellent Regulatory Affairs Job at Parexel Careers is ideal for Life Sciences and Pharmacy professionals with experience in EMA submissions, xEVMPD, Veeva Vault RIM, and EU regulatory processes. Apply today and take the next step in your regulatory career.
- Job Title: Senior Regulatory Affairs Associate
- Location: India, Remote
About the Company
Parexel is a leading global clinical research organization (CRO) that partners with biopharmaceutical and medical device companies to accelerate the development and delivery of innovative therapies. Through scientific, technical, and regulatory expertise, Parexel helps clients navigate complex regulatory requirements while supporting product development across multiple therapeutic areas. The company promotes collaboration, innovation, continuous learning, and flexible remote work opportunities.
Job Description
- Join Parexel Consulting and help biopharmaceutical and medical device companies navigate global regulatory requirements.
- Develop and support regulatory strategies to help clients bring products to market efficiently.
- Collaborate with experienced regulatory professionals and cross-functional global teams.
- Gain exposure to diverse therapeutic areas, product types, and challenging regulatory projects.
- Enjoy the flexibility of working remotely while being part of a collaborative and supportive team.
- Manage and maintain regulatory data in compliance with European Medicines Agency (EMA) requirements.
- Support EMA submissions, including xEVMPD activities and regulatory lifecycle management.
- Work with Veeva Vault RIM to manage regulatory submissions and product information.
- Ensure compliance with European regulatory guidelines for authorized and investigational medicinal products.
Key Responsibilities
- Validate and maintain regulatory data in compliance with EMA guidelines.
- Perform xEVMPD submissions and monitor submission acknowledgements.
- Support Product Lifecycle Management (PLM) activities, including variations and renewals.
- Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) submissions.
- Prepare and manage EMA documents such as eAF and eSMP.
- Maintain regulatory documents, including SmPC, PIL, and Health Authority communications.
- Support regulatory procedures, including CTA, MAA, IDMP, xEVMPD, and lifecycle management.
- Use Veeva Vault RIM for regulatory submissions, tracking, and data management.
- Ensure accurate data mapping and consistency across RIMS and DMS systems.
- Collaborate with cross-functional teams to ensure timely and compliant regulatory submissions.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
- Proven experience in Regulatory Affairs with a 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 the ability to collect, interpret, and map complex data.
- close attention to detail and strong organizational skills.
- Effective communication and teamwork abilities.
