Regulatory Affairs Consultant - Global Labeling Lead (Temporary)

Parexel • United States, United States • 1d ago

Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets?

If so, we are seeking an experienced and highly motivated strategic labeling professional to join our Global Regulatory Affairs team as a temporary Global Labeling Lead . This role will work closely our client and is integral to the development and maintenance of regulatory labeling content that supports the safe and effective use of their products across international markets. The successful candidate will provide strategic leadership in labeling development, ensure regulatory compliance, and collaborate cross-functionally to deliver high-quality documentation throughout the product lifecycle.

Key Responsibilities

Labeling Strategy & Development

Lead the creation, revision, and management of core labeling documents, including the Core Data Sheet (CDS), U.S. Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), Global Patient Leaflet, and Target Label Profile Drive alignment of labeling content and strategy across U.S., EU, and global regulatory teams Collaborate with subject matter experts to develop contingency language in response to Health Authority queries Facilitate timely endorsement of labeling decisions by senior leadership

Operational Oversight

Oversee operational labeling activities, including coordination of EU/US artwork, EMA linguistic reviews, and U.S. SPL submissions Maintain labeling documentation within electronic document management systems (EDMS) and regulatory tracking platforms

Global Implementation & Compliance

Support the regional implementation of CDS updates and monitor compliance across markets Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations Ensure audit readiness through robust version control and adherence to standard operating procedures (SOPs)

Strategic Labeling Expertise

Interpret clinical and scientific data to inform labeling content and product claims Identify strategic risks and opportunities in labeling and provide guidance to cross-functional teams Remain current with global labeling regulations and deliver training to internal stakeholders as needed

Qualifications

Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on labeling strategy and development Comprehensive understanding of US and European labeling regulations and systems to include regulatory tracking tools and artwork/supply chain platforms Demonstrated ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings Strong organizational, communication, and stakeholder engagement skills Bachelor's degree in a scientific or medical discipline; advanced degrees are preferred

Due to the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, individuals based in the Central Time Zone will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.

LI-LB1

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.

Parexel

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