Key Facts

Remote From:

India

Category: Regulatory Affairs Manager

Full time

Senior (5-10 years)

English

Hard Skills

Lifecycle Management Postmarketing Surveillance Data Management Microsoft 365

Other Skills

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Analytical Skills
•
Detail Oriented
•
Organizational Skills
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Communication
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Teamwork

Roles & Responsibilities

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)

Requirements:

Manage and maintain regulatory data for medicinal products in compliance with EMA guidelines
Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements
Support Product Lifecycle Management (PLM) activities, including variations, renewals, and regulatory updates
Prepare and manage EMA deliverables such as eAF and eSMP

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

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.