Sr. Associate I, Regulatory Affairs Strategy
Senior Associate I, Regulatory Affairs Strategy
Mexico City, Hybrid
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for talented people to join Alcon.
As a Senior Associate I, Regulatory Affairs Strategy supporting Alcon's Quality & Regulatory Affairs organization, you will be trusted to drive regulatory compliance activities, health registrations, and regulatory submissions across Mexico while supporting broader LATAM regulatory initiatives. This hybrid position offers the opportunity to work in a collaborative, fast-paced environment where your contributions directly support patient access and business growth.
In this role, a typical day will include:
- 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.
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