Senior Associate I, Regulatory Affairs Strategy

Mexico City, Hybrid
 

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

What You'll Bring to Alcon

• Bachelor's degree in Pharmaceutical Chemistry, Pharmacy, Biochemistry, Biotechnology, Biomedical Engineering, Life Sciences, or a related scientific field.
• Minimum 2 years of Regulatory Affairs experience within the pharmaceutical and/or medical device industry.
• 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.
• Experience with PromoMats, Veeva Vault, and/or Veeva RIM is preferred.
• Exposure to LATAM regulatory environments is a plus.
   

Behaviors for Success

• Learning agility and the ability to quickly adapt to new systems, processes, and regulations.
• Collaborative and team-oriented mindset.
• Self-motivated with a strong sense of ownership and accountability.
• Strong sense of urgency while maintaining quality and compliance standards.
• Flexibility to adapt to changing priorities and business needs.
• Effective communication and stakeholder management skills.
   

How You Can Thrive at Alcon

• Expand your regulatory expertise through exposure to both Mexico and LATAM regulatory activities.
• Take ownership of meaningful work that directly contributes to patient access and business success.
• Join a highly collaborative team that values learning, empowerment, continuous development, and professional growth.
• Work in a hybrid environment that promotes flexibility while maintaining strong team connection and support.