LatAm Regulatory Affairs Leader

APOTEX; Ciudad de México; Híbrido; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

APOTEX in Mexico City is seeking a Senior Regulatory Affairs professional to lead submissions, renewals, and regulatory strategies for LATAM markets. This role requires 5+ years in regulatory affairs within the pharmaceutical industry and fluency in English.

You will manage dossiers, coordinate samples, review labels, and ensure compliance with NOM standards and global guidelines, collaborating with cross-functional teams.

Formación

• Degree in BSc, QFB or QFI or related career.
• 5 years of regulatory affairs experience in pharmaceutical industry.
• Experience with Generics, OTC, food supplements, LATAM.
• Knowledge of NOM-059, NOM-073, NOM-072, NOM-177, NOM-051-SCFI, NOM-241, RTCA.

Responsabilidades

• Contribute to submissions, inclusions, renewals and modifications for LATAM per regulatory laws.
• Coordinate sample requests for submissions and renewals in LATAM.
• Review Artworks and labels per NOMs and labeling regulations.
• Prepare/update labels and certificates for products for COFEPRIS and other countries.
• Maintain internal regulatory databases and communicate status of filings.
• Support BU with RA strategy and regulatory feedback in meetings.

Conocimientos

Customer focus

Teamwork

Detail-oriented

Problem-solving

English (advanced)

Educación

BSc / QFB / QFI or related career

Descripción del empleo

APOTEX in Mexico City is seeking a Senior Regulatory Affairs professional to lead submissions, renewals, and regulatory strategies for LATAM markets. This role requires 5+ years in regulatory affairs within the pharmaceutical industry and fluency in English.

You will manage dossiers, coordinate samples, review labels, and ensure compliance with NOM standards and global guidelines, collaborating with cross-functional teams.