Senior Regulatory Affairs Associate - Global Labeling Operations

Parexel International; Northern (KY); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

401(k) with Company match

Work/Life Balance

Pet Insurance

Job summary

Parexel International is looking for a Global Labeling Specialist (Operations) to support labeling operations and regulatory compliance. This role is vital for ensuring safe use of innovative medicines globally and involves managing documents, artwork coordination, and cross-functional collaboration.

The ideal candidate has extensive experience in regulatory labeling, strong communication skills, and a commitment to quality.

Qualifications

• 3+ years of experience in pharmaceutical or biotechnology fields.
• Minimum of 2 years in regulatory labeling operations.
• Deep understanding of global labeling requirements.

Responsibilities

• Coordinate labeling operations and ensure document compliance.
• Manage regulatory-compliant labeling documents throughout product lifecycle.
• Track implementation of labeling updates across regions.

Skills

Regulatory labeling operations

Document management systems

Change management processes

Collaboration skills

Attention to detail

Education

Bachelor's degree in a scientific discipline

Tools

Regulatory tracking systems

Electronic Document Management Systems

Job description

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(R).

About the Role

We are seeking a Global Labeling Specialist (Operations) to join our team in a remote capacity. As a Global Labeling Specialist (Operations), you will support labeling operations and regulatory compliance activities that ensure safe and effective use of innovative medicines for patients and healthcare providers globally. This position plays a key role in labeling document management, regulatory compliance, artwork coordination, and maintaining labeling governance across multiple regions. You'll collaborate with cross-functional regulatory, operations, and regional teams, follow industry-standard processes, and contribute to labeling excellence from product development through lifecycle management. Responsibilities include coordinating labeling operations, managing regulatory-compliant labeling documents, overseeing regional implementation, and maintaining labeling compliance, with opportunities to deepen your expertise in global regulatory labeling and influence patient safety outcomes.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through regulatory excellence, cross-functional collaboration, and ensuring labeling governance. With diverse teams and continuous learning opportunities, the Global Labeling Specialist (Operations) can explore career paths and expand skills across regulatory affairs and clinical development.

Key Responsibilities

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to ensure changes to planned artwork activities and implementation timelines are communicated effectively

• Record regulatory assessments and ensure the Change Management System is appropriately linked to the Regulatory Tracking System

• Support the development and maintenance of regulatory-compliant, competitive, and high-quality labeling documents throughout the product lifecycle, including Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI), and US Prescribing Information (USPI)

• Distribute and track CDS updates, maintaining compliance within the Electronic Document Management System (EDMS) and regulatory tracking systems

• Track implementation of labeling updates across regions and countries, supporting Regional and Local Regulatory Leads in responding to Health Authority queries and identifying country-specific labeling differences

• Maintain labeling compliance by ensuring version control and tracking of labeling documents in relevant company systems, and create, maintain, and update regulatory labeling procedures and SOPs

• Provide training to internal stakeholders and new joiners on labeling process requirements and maintain current knowledge of global labeling regulations and governance standards

Candidate Profile

You’ll thrive in this role if you bring:

• Expertise in regulatory labeling operations, document management systems, and change management processes

• Experience working in pharmaceutical or biotechnology regulatory environments with a deep understanding of global labeling requirements

• The ability to collaborate across cross-functional teams and communicate clearly with regulatory, operations, and regional stakeholders

• A patient-focused mindset and exceptional attention to detail in managing regulatory-compliant labeling documents

• Comfort working with regulatory tracking systems, document management systems, and change management platforms

Required Qualifications

• 3+ years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations supporting innovative medicines

• Direct experience with products developed through the full drug development and registration lifecycle in an innovator company environment

• Knowledge and understanding of applicable global regulations, pharmacology, medicine, pharmacovigilance, and drug development

• Proven experience with document management systems, regulatory tracking systems, and change management platforms

• Strong communication, organization, and problem-solving skills

• Demonstrated understanding of the importance of labeling governance and compliance

Preferred Qualifications

• Bachelor's degree in a scientific or medically related discipline

• Experience with Structured Product Labeling (SPL) and FDA submission processes

• Familiarity with Electronic Document Management Systems (EDMS) and regulatory tracking platforms

• Knowledge of ICH-GCP and international regulatory requirements across multiple regions

Benefits and Compensation

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

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.

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#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.