Regulatory Strategy – LATAM Senior Associate I

Alcon; Ciudad de México; Híbrido; MXN 520.000 - 760.000; Jornada completa

Descripción de la vacante

Alcon in Mexico City is seeking a Senior Associate I in Regulatory Affairs Strategy to drive regulatory compliance, health registrations, and submissions across Mexico, supporting LATAM initiatives in a fast-paced, collaborative workflow.

The role includes managing submissions, collaborating with manufacturing, quality, and authorities, reviewing labeling, and lifecycle activities for prescription products, OTCs, and medical devices, with LATAM exposure a plus.

Formación

• Minimum 2 years of Regulatory Affairs experience in pharmaceutical and/or medical device industries.
• Experience supporting product registrations, renewals, modifications, regulatory submissions, and lifecycle management activities.
• Strong knowledge of Mexican regulatory requirements and direct experience interacting with COFEPRIS.
• Understanding of GxP regulations, SOPs, quality systems, and regulatory documentation requirements.
• Intermediate to advanced English proficiency.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Experience working with regulatory authorities and health registration processes.
• Exposure to LATAM regulatory environments is a plus.

Responsabilidades

• Manage regulatory submissions, new product registrations, renewals, and registration modifications to ensure continued compliance with local regulations.
• Collaborate with internal stakeholders, manufacturing sites, quality teams, and regulatory authorities to support timely approvals and regulatory execution.
• Support labeling reviews and ensuring compliance with applicable regulatory requirements and standards.
• Assist with advertising and promotional material reviews in accordance with Mexican regulations; LATAM regulatory exposure is a plus.
• Support regulatory strategies and lifecycle management activities for prescription products, OTC products, and/or medical devices while ensuring adherence to GxP requirements and internal procedures.

Conocimientos

Regulatory submissions

GxP knowledge

Stakeholder management

English proficiency

Project coordination

Educación

Bachelor's degree in Pharmaceutical Chemistry or related field

Herramientas

PromoMats

Veeva Vault

Veeva RIM

Descripción del empleo

Alcon in Mexico City is seeking a Senior Associate I in Regulatory Affairs Strategy to drive regulatory compliance, health registrations, and submissions across Mexico, supporting LATAM initiatives in a fast-paced, collaborative workflow.

The role includes managing submissions, collaborating with manufacturing, quality, and authorities, reviewing labeling, and lifecycle activities for prescription products, OTCs, and medical devices, with LATAM exposure a plus.