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Lead
Job summary
A global consulting firm is seeking an Assistant Global Labeling Lead to support regulatory labeling efforts. The role involves authoring and reviewing key labeling documents, coordinating updates across global markets, and ensuring compliance with regulations. Candidates should have a bachelor's degree in a related field and at least 5 years of experience in pharmaceutical regulatory affairs. Strong communication skills and attention to detail are essential for success in this position.
Qualifications
- 5+ years of experience in pharmaceutical regulatory affairs, labeling, or related scientific functions.
- Experience with global labeling standards, including CCDS, USPI, and EU SmPC.
Responsibilities
- Assist in authoring, editing, and updating labeling documents.
- Review scientific and regulatory information for labeling content.
- Collaborate with global teams for consistency in labeling.
Skills
Education
Position Title : Assistant Global Labeling Lead
Location : Colombia / Mexico - Remote
Permanent
Function : Global Regulatory Labeling
Position Overview : The Assistant Global Labeling Lead (AGLL) will support the 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.
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 the preparation of labeling submission packages for regulatory authorities.
Ensure labeling documents align with overall regulatory and commercial strategies.
- 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.
- Experience with global labeling standards, including CCDS, USPI, and EU SmPC; additional regional labels are a plus.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.