Regulatory Affairs Labeling

Parexel; United States; Remoto; USD 120.000 - 140.000; Tempo pieno

Descrizione del lavoro

Parexel is seeking a Regulatory Labeling Specialist to join remotely. You will ensure medicinal product labeling remains accurate, compliant, and current across lifecycle, collaborating with cross-functional teams and clients to support regulatory outcomes.

You will work with Health Authority submissions, CCDS updates, and post-approval activities in Veeva RIMS and TrackWise, contributing to a fast-paced, growth-focused environment that prioritizes patient safety and regulatory excellence.

Competenze

• Bachelor's degree in Life Sciences or related field with 6+ years in regulatory labeling.
• Experience with Health Authority submissions and CCDS updates.
• Proficiency in English with strong written and verbal communication.
• Knowledge of Veeva RIMS and TrackWise workflows.

Mansioni

• Perform regulatory impact assessments for change controls and submissions.
• Manage product information updates, including CCDS creation and updates.
• Prepare and submit variations, notifications, and renewals to Health Authorities.
• Respond to Health Authority questions on submissions.
• Coordinate labeling updates and translations with team members and clients.

Conoscenze

Regulatory labeling

Veeva RIMS

TrackWise

Cross-functional collaboration

English fluency

Project coordination

Formazione

Bachelor’s degree in Life Sciences

Strumenti

Veeva RIMS

TrackWise

Descrizione del lavoro

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.

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

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.