Senior Regulatory Affairs Associate / Consultant - Labeling Operations (Long term temp)
United States of America, Remote Additional Locations Canada-Ontario-Remote; Job ID R0000032593 Category Consulting Date Posted 04/01/2025Overview
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
Fantastic opportunity to bring your labeling operations experience to Parexel as a temporary employee supporting a large client partnership with their labeling strategy and ensuring that labeling documents are of high quality and compliant for the safe and effective use of their products for patients and healthcare providers globally.
As a Global Labeling Senior Regulatory Affairs Associate / Consultant, you will be responsible for:
Artwork coordination between Regulatory/Labeling and Artwork/Change Management teams
Structured Product Labeling (SPL) management
Supporting the development and maintenance of core, EU and US labeling documents
Tracking core labeling implementation at a regional/country level
What You’ll Do
Labeling Operations:
Act as intermediary between Regulatory/Labeling and Artwork/Change Management Teams to ensure changes to the planned artwork activity and implementation timelines are communicated
Record regulatory assessments and ensure Change Management System is appropriately linked to the Regulatory Tracking System
Support the Regulatory/Labeling team to provide the SPL version of the USPI to the FDA via a vendor
Create and update labeling documents:
Support the development/ maintenance of regulatory compliant, competitive and high-quality labeling documents throughout the product lifecycle including the Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI) and US Prescribing Information (USPI)
Support the cross functional product labeling team on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management
Distribute and track CDS updates, maintaining compliance within the Electronic Document Management System and the regulatory tracking system
Support the delivery of EUPI and USPI according to company strategy, Health Authority regulations and timelines
Oversee regional/country implementation:
Track implementation of CDS updates, maintaining compliance within the EDMS and the Regulatory Tracking System
Support Regional and Local Regulatory Leads in responding to Health Authority queries related to labeling and collaborate with Regulatory Leads to identify and track Country Labeling Differences
Maintain labeling compliance:
Maintain labeling compliance, ensuring version control and tracking of labeling documents in relevant company systems
Create, maintain and update regulatory labeling procedures and SOPs and support relevant audits and inspections
Maintain knowledge of current rules and regulations governing global labeling activities
Provide training to internal stakeholders and new joiners on labeling process requirements
Who You Are
You will have a passion for regulatory labeling and an excellent eye for detail.
You will also have a demonstrated understanding of the importance of labeling governance and compliance.
You will have an interest in working closely with this team for at least the next 6-12 months with the possibility of extension
Required Skills
3+ years pharmaceutical/biotechnology industry experience (at least 2 years in regulatory labeling)
Knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development
Proven experience with document management, regulatory tracking and change management systems
Preferred Skills
Bachelor's degree in a scientific or medically related discipline preferred
Due to the location of the client, candidates located in the EST are strongly preferred
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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