Regulatory Labeling Specialist

Regulatory Labeling Specialist

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a Regulatory Labeling Specialist to join our team in a remote capacity. As a Regulatory Labeling Specialist, you will ensure that medicinal product information remains accurate, compliant, and current throughout its lifecycle. Accurate labeling helps patients and healthcare professionals get the information they need about medicines. This position plays a key role in regulatory impact assessment, product information management, Health Authority submissions, and post-approval compliance. You will collaborate with cross-functional teams and client stakeholders, follow industry-standard processes, and contribute to regulatory and labeling operations from planning through post-approval activities.

Responsibilities include assessing the regulatory impact of change controls, managing product information and labeling updates, preparing Health Authority submissions, and driving post-approval activities in Veeva RIMS, with opportunities to deepen your expertise and influence regulatory outcomes.

You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through regulatory impact assessment, product information management, and Health Authority submissions. With diverse teams and continuous learning opportunities, the Regulatory Labeling Specialist can explore career paths and expand skills across regulatory affairs.

Key Responsibilities

• Perform regulatory impact assessments for change controls raised in TrackWise for medicinal products registered via the Centralized Procedure (CP), Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP), or National Procedure (NP)
• Manage product information updates, including creation and updates of the Company Core Data Sheet (CCDS), applying clinical expertise
• Prepare and submit variations, notifications, and renewals to Health Authorities
• Respond to Health Authority questions on submissions
• Coordinate labeling updates, including translations, with team members and client stakeholders
• Manage all required post-approval activities in Veeva Regulatory Information Management System (RIMS), including artwork updates

You'll thrive in this role if you bring:

• Strong coordination skills and the ability to work effectively with team members and client stakeholders

• Strong planning skills, including planning variation submissions so they are completed on time and to the required quality to meet KPIs

• Clear communication skills and a collaborative, team-oriented approach

• Experience working in clinical research, healthcare, or a regulated environment

• A patient-focused mindset and strong attention to detail

• Comfort working with Veeva RIMS and TrackWise

• Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field, or equivalent professional experience

• 6 +years of experience in regulatory affairs or regulatory labeling

• Knowledge of regulatory requirements and Health Authority submission processes for medicinal product labeling

• Clinical expertise to support product information and CCDS updates

• Knowledge of Veeva RIMS

• Fluent in English

• Strong communication, organization, and planning skills

• Preferred Qualifications

• Experience with xEVMPD

• If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be perfect fit, send them the link to apply!

• We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

• LI-REMOTE

• 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 grow and be successful.

• Learn more

• Medical Writing at Parexel

• Join a global team of 700+ medical writers transforming complex scientific data into clear communications that advance therapies and improve patient care.

• Learn more

• A day in a life of a Project Leader

• Christine and Ewa share what a Project Leader does, why to become a Project Leader, and what mindset is needed. Explore how a Project Leader resembles a cheerleader or a coxswain of a rowing boat!

• Learn more

• FSP Integrated Solutions Jobs at Parexel

• Explore FSP Integrated Solutions careers at Parexel, where dedicated customer partnerships, specialized experience and opportunities across clinical development help professionals grow their careers while advancing therapies for patients worldwide.

• Learn more

• Clinical Data Operations at Parexel

• Explore career paths through the eyes of our Data Managers, Biostatisticians, and Statistical Programmers. Learn what drives them, how they've grown at Parexel, and what makes working in Data Operations rewarding.

• Learn more

• Meet Joanna: Principal Medical Writer

• Joanna provides insights about her role as a Principal Medical Writer. She describes what excites her about the role and what it is like working with highly educated, motivated, and professional colleagues.

• Learn more

• Meet Mary: Principal Medical Writer

• Mary provides insights about her role as a Principal Medical Writer. She shares what it is like working with her fellow colleagues, how Parexel has supported her career development, and what excites her most about the work she does.

• Learn more

• Meet Santino: Senior Clinical Operations Leader

• Santino's career at Parexel, from a Project Specialist to a Sr. Clinical Operations Leader, showcases a diverse journey through Clinical Operations, fueled by a passion for the pharmaceutical industry and a commitment to impacting patient lives. His experience highlights Parexel's dedication to professional growth and the embodiment of the "We Care" promise in every facet of their work.

• Learn more

• Meet Simona, Vice President Technical in Regulatory Strategy

• Discover how Simona transformed her medical background and regulatory agency experience into a fulfilling career at Parexel. Learn how this VP Technical in Regulatory Strategy leverages her unique expertise to impact patient lives while enjoying professional growth, work-life balance, and collaborative culture in a global CRO environment.

• Learn more

• Meet Catherine: Associate Project Director

• People are Catherine's passion. She enjoys showing a project team how their work fits into the bigger picture, sharing knowledge and celebrating accomplishments. Explore her career advice, newly established behaviors, and more!

• Learn more

• Meet Dorothy: Senior Document Quality Reviewer

• Dorothy shares her story about returning to work after a career break, and how she arrived at Parexel, having previously worked for another CRO. Dorothy even draws comparisons between Par