Regulatory Affairs Analyst São Paulo
Conduct and coordinate JJV regulatory activities for Brazil.
Support JJV regulatory activities for South Hub.
In partnership with RA management, support the execution of Brazil and South Hub regulatory strategies for new and existing products.
In partnership with RA management, support the implementation of Brazil and South Hub objectives based on JJV business priorities, and global regulatory strategies and plans in support of JJV business regulatory imperatives.
Work with RA management to ensure rapid and timely approval of new products and continued Regulatory support of products marketed in Brazil.
In partnership with RA management, support the implementation of Brazil and South Hub 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.
Support the implementation and maintenance of the appropriate regulatory framework (processes, procedures... standards, etc.) to facilitate efficiency and compliance.
Support the preparation of Brazil RA budget.
Conduct activities concerned with the submission and approval of products to government regulatory agencies in Brazil.
Request and monitor the technical and legal documentation of the companies originating from all over the world to prepare the regulatory submissions and files.
Request and monitor technical regulatory projects such as translations of legal and technical documents.
Prepare responses to regulatory agencies' questions and other correspondence.
In partnership with RA management, assemble information necessary for submissions in accordance with regulations and relevant guidelines.
Organize and maintain reporting schedules for new drug / medical devices applications.
Assist with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Ensure compliance with regulatory agency regulations and interpretations.
Ensure adherence to applicable regulations in product registration and promotional materials, standard operating procedures and protocol for the rapid and timely approval of new drugs / medical devices and regulatory support of marketed drugs / medical devices and other products.
In partnership with RA management, interact with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.
Provide solutions to a variety of problems of moderate scope and complexity.
Ensure timely and accurate promotional materials review and approval and HA notification according to local advertising legal requirements.
Evaluate proposed product modifications for Regulatory impact, completing Regulatory Assessments as needed.
Ensure the update and maintenance of products registration and listing, as well as establishment/facilities licensing.
Update relevant global, regional and local databases to ensure compliance.
Conduct searches of existing files for requested information.
Maintains and archives all regulatory documentation.
Provide regulatory support to inspections/audits by producing requested documents or answering any inquiries for information.
Qualifications
REQUIRED
BachelorÂ’s degree;
Experience in Regulatory Affairs area
English advanced
DESIRABLE
INMETRO e ANATEL certifications
Experience in Regulatory area in a regulated industry (could include pharmaceutical, medical device, or associated consumer industries)
Spanish Advanced
Primary Location
Brazil-São Paulo-São Paulo-AVENIDA PRESIDENTE JUSCELINO KUBITSCHECK, 2041
Organization
Abbott Prod Oticos Ltda (7602)
Job Function
Regulatory Affairs
Requisition ID
3875201009
São Paulo State of São Paulo Brazil
Regulatory Affairs Analyst São Paulo Johnson & Johnson Family of Companies São Paulo
