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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
São Paulo BrazilJob 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: Bachelors 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 AffairsPreferred 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 ThinkingRequired Experience:
Director
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more