Remote Senior Labeling Strategist

Parexel; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Parexel is seeking a Labelling Strategist to join as a Senior Associate Regulatory Affairs in a remote capacity. You will support the development and management of global labeling strategies that advance therapies, ensuring regulatory compliance across markets and lifecycle management from development through post-approval activities.

You will collaborate with regulatory, quality, and commercial teams to oversee labeling documents, submissions, and artwork changes, while driving alignment with

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field.
• 7–8 years of experience in pharmaceutical regulatory affairs, with demonstrated expertise in labeling development and post-approval activities.
• In-depth knowledge of labeling regulations and guidelines across major markets (US, EU, Switzerland, Canada, Australia).
• Hands-on experience with CCDS-related submissions, safety variations, and artwork management.
• Proficiency in SPL and document management systems.

Responsibilities

• Develop, maintain, and update global labeling documents including CCDS, USPI, and regional labels for US, EU, Switzerland, Canada, Australia, and other markets in alignment with regulatory requirements and PRAC/CMDh recommendations
• Manage all post-approval labeling activities including artwork updates, safety variations, xEVMPD submissions, and PSURs with strong attention to regulatory compliance
• Conduct Regulatory Impact Assessments for change controls raised for medicinal products in registered markets
• Coordinate artwork approval processes for printed packaging components, ensuring compliance with design and regulatory requirements for new products, new packs, and packaging changes
• Demonstrate proficiency in SPL across all aspects and troubleshooting, and manage the review and approval of labeling in document management systems
• Monitor and manage artwork change requests, oversee operational processes for artwork creation and translation, and maintain Artwork Trackers and related systems
• Research and prepare comparator labeling documents for global alignment and competitive analysis
• Author labeling components of Annual Reports and maintain compliance with regulatory standards
• Liaise with internal and external stakeholders to ensure timely and accurate implementation of labeling changes across regions

Skills

Regulatory affairs

Labeling strategy

Cross-functional

Global submissions

SPL proficiency

Documentation management

Education

Bachelor’s degree in Life Sciences

Master’s degree preferred

Tools

Veeva

TVT

Docubridge

Job description

Parexel is seeking a Labelling Strategist to join as a Senior Associate Regulatory Affairs in a remote capacity. You will support the development and management of global labeling strategies that advance therapies, ensuring regulatory compliance across markets and lifecycle management from development through post-approval activities.

You will collaborate with regulatory, quality, and commercial teams to oversee labeling documents, submissions, and artwork changes, while driving alignment with