Lead

hace 2 semanas

Mexico City Avance Consulting A tiempo completo

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.

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 the preparation of labeling submission packages for regulatory authorities.
- Ensure labeling documents align with overall regulatory and commercial strategies.

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.
- Experience with global labeling standards, including CCDS, USPI, and EU SmPC; additional regional labels are a plus.

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