About Freyr.
Freyr Life Sciences. 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: Assistant Global Labeling Lead
Location: Princeton NJ (Remote)
Job Type: Permanent, Full-Time
Position Overview:
The Assistant Global Labeling Lead (AGLL) will support Freyr’s Client by assisting the Global Labeling Lead (GLL) in authoring, reviewing, and maintaining key labeling documents such as Core Company Data Sheets (CCDS), US Prescribing Information (USPI), and local labeling across global markets. The role includes coordinating labeling updates, supporting submission activities, ensuring compliance with regulatory requirements, and collaborating with global and regional teams. Strong communication, scientific understanding, and attention to detail are essential for success.
Responsibilities:
Assist in authoring, editing, and updating CCDS, USPI, and other labeling documents in alignment with regulatory requirements and internal standards.
Review scientific, clinical, and regulatory information to support high-quality labeling content.
Collaborate with the GLL to ensure consistency between global labeling and regional/local market requirements.
Coordinate labeling updates across global markets and maintain accurate version control.
Support preparation of labeling submission packages for regulatory authorities.
Ensure labeling documents align with overall regulatory and commercial strategies.
Address labeling-related questions from affiliates and regulatory authorities.
Maintain accurate documentation and ensure compliance with internal SOPs and industry regulations.
Work closely with cross-functional teams with strong communication and collaboration skills.
Minimum Education and Experience:
Bachelor’s degree in Pharmacy, Life Sciences, or a related field (preferred).
Minimum 5 years of experience in pharmaceutical regulatory affairs, labeling, or related scientific functions.
Strong understanding of scientific principles and regulatory/quality systems related to drug development.
Experience with global labeling standards including CCDS, USPI, and EU SmPC; additional regional labels are a plus.
Excellent oral and written communication skills in English.
Comfortable presenting to groups of varying sizes.
Knowledge & Other Requirements:
Knowledge of global labeling regulations, standards, and processes.
Strong attention to detail with the ability to manage multiple tasks and timelines.
Ability to collaborate effectively with cross-functional and global teams.
Proficiency with regulatory systems and document management platforms.
Strong organizational skills and ability to maintain oversight of labeling processes.
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 Life Sciences. 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.
