Regulatory Affairs Senior Specialist Sao Paulo, Brazil

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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About Vision

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments Ready to join a team thats reimagining how vision is improved Our Vision team solves the toughest health challenges. Help combine cutting-edge insights science technology and people to encourage eye care professionals and patients to proactively protect correct and enhance healthy sight for life. Our products and services address these needs from the pediatric to aging eye in a patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Regulatory Affairs Senior Specialist.

Purpose: Coordinates compiles and submits new/existing products applications abbreviated new/existing products applications and investigational new products applications to the Regulatory Agencies in Brazil.

You will be responsible for:

In partnership with Subregional Leader supports the execution of regulatory strategies for new and existing products for Brazil.

In partnership with Subregional Leader supports the implementation of objectives for Brazil based on JJV business priorities and regional regulatory strategies.

Liaises with the LATAM Regulatory Operations team and executes registration strategies for designated regional projects related to new/existing products according to local regulation approved licenses and RA Country alignment.

Responds to product information related to local requests or designated regional projects.

Works with Subregional Leader to ensure rapid and timely approval of new products and continued Regulatory support of products marketed in Brazil.

In partnership with Subregional Leader supports the implementation of regulatory strategies and processes to ensure timely commercialization of new or modified products in the market in compliance with current and appropriate local regulatory expectations.

Implements and maintains the appropriate regulatory framework (processes procedures standards etc.) to facilitate efficiency and compliance.

Controls expenses to support the preparation and management of RA budget for Brazil.

Conducts activities concerned with the submission and approval of designated projects to government regulatory agencies in Brazil.

Partners with LATAM Regulatory Operations team to define and obtain the deliverables to assist with the designated projects submissions.

In partnership with the Subregional Leader interprets regulatory requirements and oversees aspects of local submissions including assessment of the impact product changes have on the status of regulatory licenses.

Prepares regulatory labeling requirements specifications for new and modified products and reviews product labeling to ensure compliance.

Represents Regulatory Affairs on cross-functional project teams under her/his scope.

Prepares responses to regulatory agencies questions and other correspondence.

Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.

Organizes and maintains reporting schedules for new drug / medical devices applications.

Involved with the preparation of necessary outlines summaries status reports memos graphs charts tables and slides.

Ensures compliance with regulatory agency regulations and interpretations.

In partnership with Subregional Leader interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.

Provides solutions to a variety of problems of moderate scope and complexity.

Ensures timely and accurate promotional materials review and HA notification according to local advertising legal requirements.

Supports the evaluation of proposed product modifications for Regulatory impact and the completion of Regulatory Assessments as needed.

Ensures the update and maintenance of products registration and listing.

Updates relevant global local databases to ensure compliance.

Conducts searches of existing files for requested information.

Maintains and archives regulatory documentation.

In partnership with Subregional Leader provides regulatory support to inspections/audits by producing requested documents or answering any inquiries for information.

Qualifications / Requirements:

Bachelors degree with a minimum of 4-6 years of Regulatory experience in a regulated industry (Mainy in Medical Devices could include pharmaceutical or associated consumer industries).

Fluent in English & Portuguese (Mandatory) Spanish is desirable

Result-oriented initiative proactive

Accountability and ownership

Team player and collaboration

Ability to prioritize multiple tasks and projects

Good communication skills (collaborative approach) open-minded

Very strong regulatory knowledge of regulations in the region

Able to analyze information with complex scope to make autonomous decisions and formulate clear advice

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