Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)

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Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)

Primary Location: Italy, Remote Additional Locations: Croatia, Remote; Czech Republic, Remote; Hungary, Remote; Lithuania, Remote; Poland, Remote; Poland, Warsaw; Romania, Remote; Serbia, Belgrade; Serbia, Remote Job ID R0000041583 Category Regulatory / Consulting Date Posted 05/07/2026

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• Success profile
• About this role
• Employee insights
• Why Consultants work at Parexel
• Learn about our culture
  
  

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
  
  

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About This Role

Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Senior Regulatory Affairs Associate to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.

As the Senior Regulatory Affairs Associate you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological and vaccines products.

Primary Tasks & Responsibilities

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
  
  

Experience And Knowledge Requirements

• University-level education, preferably in Life Sciences, or equivalent by experience.
• Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
• Knowledge of biological or vaccines processes.
• Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
• Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
• Team spirit, flexibility, accountability, and organizational skills.
• Fluent in English (written and spoken).
  
  

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Employee Insights

How to describe Parexel culture in one word

Insights from Parexel employees

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Jo on diverse project work and team culture

Jo Wang | Vice President, Technical

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Kurt Brorson | Vice President, Technical

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Why Consultants work at Parexel

Patient-led in everything we do

We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.

Supportive and inclusive environment

We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.

Opportunities for career growth

We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.

Flexible work arrangements

We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment.

Diverse and global client exposure

We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval.

Learn from experts

You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career.

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Learn About Our Culture

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• Emerging Talent Opportunities
  
  

Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind.

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• Benefits & Support
  
  

At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture.

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• Inclusion at Parexel
  
  

Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment.

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