US Labeling Execution Specialist – US Pacific Time Zone – Freyr Solutions

About Freyr.

Freyr Inc. is a global leader in regulatory solutions and services within the life sciences industry. Freyr specializes in providing Regulatory Affairs, Pharmacovigilance, and Quality Assurance services. With a diverse team worldwide, we deliver efficient and compliant regulatory solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer healthcare sectors.

Job Title: US Labeling Execution Specialist – Pacific Time Zone Support

Location: Remote – Canada

Employment Type: Indefinite/Permanent

Role Overview:

Freyr is seeking a detail-oriented and experienced US Labeling Execution Specialist to support labeling operations and regulatory labeling activities for Freyr’s Client. The role involves preparation, proofreading, updating, execution, and maintenance of labeling documents in compliance with Health Authority requirements, internal standards, and global regulatory processes.

The ideal candidate should possess strong expertise in pharmaceutical labeling operations, document management, proofreading, and SPL-related activities, along with the ability to manage multiple priorities in a fast-paced regulatory environment.

Key Responsibilities

Labeling Operations & Execution

• Author, update, and maintain labeling documents such as USPI and applicable regional Prescribing Information (PI) documents in alignment with Health Authority approvals, CCDS updates, and internal standards.
• Review approved USPI corresponding to SPL actions and perform Approved Text Review activities.
• Support preparation and documentation of US labeling updates for regulatory submissions, including EDMS support and SPL activities.
• Coordinate labeling updates across global markets while maintaining version control and tracking changes.
• Act as the first layer quality reviewer for draft labeling documents.
• Provide proofreading support for labeling documents against approved text, applicable regulations, and internal standards.
• Perform formatting, technical/scientific content checks, and alignment to regional templates and client reference guides.
• Review labels for compliance with applicable regulatory requirements and internal policies.
• Monitor and track innovator labels and labeling updates.

Regulatory Support

• Support drug listing and registration activities, including:
• Product Drug Listings
• Establishment Registration support
• Lot Distribution Reports
• Blanket No Change Notifications
• Support Annual Report Labeling Summaries and provide labeling components for NDA/BLA Annual Reports.
• Track and update client systems related to labeling events, including document uploads, communication updates, notifications, and milestone tracking.

Documentation & Stakeholder Coordination

• Manage global labeling mailboxes, triage requests, archive communications, and route queries to appropriate stakeholders.
• Maintain labeling folders and documentation within Freyr and client systems.
• Respond to labeling execution-related queries from internal and external stakeholders.
• Ensure labeling documentation is accurate, organized, and compliant with internal SOPs and regulatory expectations.
• Collaborate effectively with cross-functional teams to ensure timely and high-quality deliverables.

Qualifications & Experience

Education

• Bachelor’s degree in Pharmacy, Life Sciences, Medical Devices, or related scientific discipline preferred.

Experience

• Minimum 3 years of experience in Regulatory Affairs, Regulatory Labeling, or related pharmaceutical regulatory functions.
• Hands-on experience in preparation, updating, proofreading, and execution of labeling documents.
• Experience supporting labeling operations for pharmaceutical products is strongly preferred.

Technical Skills

• Understanding of pharmaceutical labeling regulations and compliance requirements.
• Familiarity with workflow management systems and industry-standard regulatory tools.
• Proficiency in Microsoft Office applications including Word, Excel, and Outlook.
• Strong document management and proofreading capabilities.
• Ability to manage multiple priorities and work under tight timelines.

Soft Skills

• Excellent attention to detail and organizational skills.
• Strong communication and collaboration abilities.
• Ability to work effectively in a fast-paced, deadline-driven environment.

Why Join Us?

Flexibility: Enjoy remote work with opportunities for client travel and industry engagement.

Growth Opportunity: Be part of a fast-growing, global organization at the forefront of life sciences regulatory consulting.

Innovation: Work with cross-functional teams delivering cutting-edge solutions to industry leaders.

Equal Opportunity Employer

Freyr Inc. is an equal opportunity employer and values diversity at our company. All qualified applicants will receive consideration for employment without regard to race, religion, gender, sexual orientation, national origin, or disability status.