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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

São Paulo, Brazil

Job Description:

Position Summary:

We are seeking an experienced Regulatory Affairs (RA) leader to join our Team. This role provides end-to-end RA leadership for our vision business across the Latin America region, ensuring compliance, driving regulatory strategy, shaping policy and enabling successful product registrations and lifecycle management.

Key Responsibilities:

• Strategic Leadership:

  • Develop and execute regional regulatory strategies aligned with global objectives for ophthalmic products (devices, diagnostics, and combination products).

  • Represent Latin America on the Global RA Leadership Team, influencing global policy and strategy.

  • Serve as a key member of the Latin America Commercial Leadership Team, partnering to enable market access and growth.

• Regulatory Operations:

  • Oversee all regulatory submissions, approvals, post-market compliance and promo material review process for the ophthalmic portfolio in Latin America.

  • Ensure timely product registrations and lifecycle management across diverse regulatory environments.

  • Maintain strong relationships with regional health authorities and industry associations.

• Cross-Functional Collaboration:

  • Partner with Global RA, R&D, Quality, Clinical, and Commercial teams to support new product introductions,  labeling and promo material compliance in Latin America.

  • Provide regulatory input on promotional materials and commercial initiatives.

• Leadership & Talent Development:

  • Build and lead a high-performing regional RA team.

  • Foster a culture of compliance, innovation, and continuous improvement.

• External Environment Shaping:

  • Engage proactively with regulatory agencies, trade associations, and policy makers to shape evolving regulatory frameworks in Latin America.

  • Monitor and anticipate regulatory trends, providing strategic input to global teams.

  • Advocate for science-based regulations that support innovation and patient access.

Qualifications:

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field; advanced degree preferred.

• Experience:

  • Minimum 10 years in Regulatory Affairs, with at least 5 years in leadership roles.

  • Proven track record in ophthalmic products or medical devices.

  • Deep understanding of Latin American regulatory frameworks and global RA processes.

• Skills:

  • Strong strategic thinking and ability to influence at senior levels.

  • Excellent communication and negotiation skills.

  • Fluent in English (required); Spanish and/or Portuguese highly desirable.

• Other: Ability to travel regionally and internationally as needed.

 

 

Required Skills:

Drug Regulatory Affairs

 

 

Preferred Skills:

Business Writing, Collaborating, Continuous Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Compliance, Strategic Thinking