POSITION SUMMARY: Coordinate, compile, and submit new drug / medical devices applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies.
Essential Functions / Responsibilities
- Plan, conduct and coordinate JJV regulatory activities for Brazil.
- In partnership with RA management, establish and execute Brazil regulatory strategies for new and existing products.
- In partnership with RA management, develop and implement Brazil 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, develop and implement Brazil 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.
- Coordinate activities concerned with the submission and approval of products to government regulatory agencies in Brazil.
- Provide regulatory advice to project teams.
- 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.
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
- Organize and maintain reporting schedules for new drug / medical devices applications.
- Involved with the preparation of 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.
- Archive documents and correspondence submitted to and received from the Authority according to the global and local agreed processes.
- Provide regulatory support to inspections/audits by producing requested documents or answering any inquiries for information.
- A Bachelor’s degree with a minimum of 4 years of Regulatory experience in a regulated industry
- Fluent in English and Portuguese (both written and verbal)
- Spanish will be consider a plus
- Result-oriented, initiative, proactive
- Team player
- Good communication skills (collaborative approach), open-minded
- Demonstrated ability to handle multiple projects
- Regulatory knowledge of Brazilian regulations in Medication or Medical Devices
- This position is based at Brazil Johnson & Johnson site, and may require up to 5 – 10% travel
Local: São Paulo
Empresa: J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda
Cargo: Regulatory Affairs
Para se candidatar a esta vaga cadastre seu currículo em https://jobs.jnj.com/jobs/1609190807