Senior Regulatory Affairs Associate

Parexel

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

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, offering flexibility in working location across various European locations, either office or home based.

As the Senior Regulatory Affairs Associate in Safety Labelling, you will plan, coordinate, and deliver global and regional safety labelling activities and regulatory submissions throughout the product lifecycle. You will act as the primary Global Regulatory Affairs contact for assigned safety labelling activities, working closely with client stakeholders, affiliates, and internal cross-functional teams.

Key Responsibilities

• Plan, coordinate, and deliver global and regional safety labelling activities and regulatory submissions throughout the product lifecycle, ensuring timely execution and compliance with applicable regulatory requirements.

• Execute high-quality safety labelling regulatory activities, maintaining compliance with client procedures, regulatory requirements, and internal systems and processes.

• Assess emerging safety information, regulatory commitments, and pharmacovigilance outputs to determine labelling impact, submission requirements, implementation timelines, and associated regulatory risks.

• Author, review, and maintain regulatory documentation, including Module 1 content, and collaborate with subject matter experts and stakeholders to prepare submission-ready dossiers.

• Manage end-to-end safety labelling submissions, including planning, dossier compilation, submission package preparation, RIMS maintenance, health authority query responses, and post-approval implementation activities.

• Serve as the primary Global Regulatory Affairs contact for assigned safety labelling activities, coordinating with client stakeholders, affiliates, and internal cross-functional teams.

• Maintain and oversee global and regional product information, including EU Product Information, ensuring compliance with applicable regulations, QRD requirements, company core labelling documents, and client standards.

• Coordinate and track linguistic review, translation, readability testing, and implementation activities associated with safety labelling updates.

• Support the development, maintenance, and implementation of Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI), and associated local labelling documentation, where applicable.

• Provide regulatory support for safety-related updates arising from Periodic Safety Update Reports (PSURs), signal evaluations, risk management activities, and other pharmacovigilance-driven initiatives.

• Support change control processes related to safety labelling updates and ensure approved changes are implemented within required regulatory timelines.

• Coordinate with publishing, operations, and affiliate teams to support the assembly, validation, submission, and implementation of regulatory dossiers.

• Liaise with health authorities, affiliates, and other stakeholders regarding routine and non-routine safety labelling matters, including responses to regulatory questions and requests for information.

• Monitor and communicate relevant changes to global regulatory requirements, guidance, and labelling standards that may impact product compliance or labelling strategy.

• Develop and maintain submission plans, trackers, metrics, and regulatory records to support inspection readiness, compliance monitoring, and on-time delivery of regulatory commitments.

• Contribute as an active member of cross-functional regulatory and safety governance teams, providing regulatory expertise and support for complex labelling initiatives.

• Skills and Experience

• University degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline.

• Working knowledge of global and regional regulatory requirements for medicinal product safety labelling and lifecycle management, including EU labelling requirements.

• Understanding of CCDS, CCSI, and their implementation into product information and artwork.

• Knowledge of safety signal management and the impact of confirmed safety signals on product labelling.

• Understanding of regulatory submission processes, including Module 1 documentation, lifecycle management activities, and health authority interactions.

• Familiarity with Regulatory Information Management Systems (RIMS) and electronic document management systems.

• Strong planning, organizational, and time management skills, with the ability to manage multiple priorities and deadlines.

• Strong analytical and problem-solving skills, with the ability to interpret regulatory requirements and propose practical solutions.

• Excellent communication, stakeholder management, and interpersonal skills, with the ability to collaborate effectively across cross-functional teams.

• Fluent in English, both written and spoken.

LI-REMOTE

Employee Insights

How to describe Parexel culture in one word

Insights from Parexel employees

Watch Video

Jo on diverse project work and team culture

Jo Wang | Vice President, Technical

Watch Video

Kurt on colleagues and growth opportunities

Kurt Brorson | Vice President, Technical

Watch Video

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.

Learn About Our Culture

Careers in Neuroscience

Neuroscience diseases affect the very core of one’s being and experience. We work diligently to lighten the burden for patients and families alike. Explore opportunities to join our team.

Learn More

Careers in Cell and Gene

Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space.

Learn More

Our work culture

Learn about our culture, perks, learning opportunities, and our corporate responsibility approach. Parexel's compassionate and results-driven work culture prioritizes patient care and employee growth.

Learn More

Careers in Oncology

Our dedicated people, innovative approaches, and culture of caring all work together to ease the journey for patients and investigators.

Learn More

Careers in Rare Diseases

In rare disease, every single patient is precious. Discover where your skills can create a life-changing achievement for every person involved.

Learn More

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.

Learn More

Parexel’s hiring process

It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can