Lead

Avance Consulting; A distancia; MXN 1,257,000 - 1,617,000; Jornada completa

Descripción de la vacante

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.

Formación

• 5+ years of experience in pharmaceutical regulatory affairs, labeling, or related scientific functions.
• Experience with global labeling standards, including CCDS, USPI, and EU SmPC.

Responsabilidades

• Assist in authoring, editing, and updating labeling documents.
• Review scientific and regulatory information for labeling content.
• Collaborate with global teams for consistency in labeling.

Conocimientos

Strong communication

Scientific understanding

Attention to detail

Educación

Bachelor's degree in Pharmacy, Life Sciences, or a related field

Descripción del empleo

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.

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.