Expires soon Johnson And Johnson

ANALISTA DE ASSUNTOS REGULATORIOS PL - VISION - SÃO PAULO/SP

  • São Paulo (São Paulo)
  • Bachelor's Degree
  • Community management

Job description

Job Description

Requisition ID: 6795190207


POSITION SUMMARY:

Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Organizes and maintains reporting schedules for new drug / medical devices applications. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope of complexity. Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

• Work under supervision to conduct regulatory activities for Brazil and South Hub and to meet department and company objectives.
• Work with Management to ensure rapid and timely approval of lifecycle products and continued Regulatory support of products marketed in Brazil and South Hub.
• Assist to implement processes, standards and trainings that ensure a continuous high Regulatory compliance level.
• Ensure conformance with applicable regulations in product registration and promotional materials, standards and all regulatory requirements (e.g. timely submission of dossiers, timely implementation and training of SOP's & supporting systems).
• Ensure alignment with business objectives and timely response.
• Support the identification, assessment and communication of any new external regulatory requirements (e.g. regulations, standards, etc.) in Brazil that could impact the business.
• Under supervision, coordinate, compile, and submit Regulatory documents of Lifecycle products to competent authorities, Regulatory Agencies and business partners in Brazil and South Hub.
• Request and monitor the technical and legal documentation of the companies originating from all over the world to prepare the registration dossiers.
• Request and monitor technical regulatory projects such as translations of legal and technical documents.
• Under supervision, prepare responses to health authority questions and other Regulatory correspondence.
• Under supervision, interacts with regulatory agency personnel in order to seek guidance, expedite approval of pending applications and to resolve regulatory matters
• Under supervision, gather and assemble information necessary for submissions of Lifecycle products in accordance with regulations and relevant guidelines.
• Ensure timely and accurate promotional materials review and approval and HA notification according to local advertising legal requirements.
• Under supervision, evaluate proposed product modifications for Regulatory impact, completing Regulatory Assessments as needed.
• Assist the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Ensure the update and maintenance of products registration and listing, as well as licensing.
• Update relevant global, regional and local databases to ensure compliance.
• Archiving of all documents and correspondence submitted to and received from the Authority according to the globally and locally agreed processes
• Under supervision, provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.

Desired profile

Qualifications
• University/Bachelor`s Degree – pharmacy, life-science or health-related discipline (preferred)
• Experience in Regulatory Affairs in Medical Devices or Drug preferably
• Fluent in Portuguese and knowledge of English and Spanish language, sufficient for business communication purposes
• Result-oriented, initiative, proactive
• Team player
• Good communication skills (collaborative approach), open-minded
• Demonstrated ability to handle multiple projects
• Some regional business travel (5 - 10%) may be required. Occasional international travel may be required.
Primary Location
Brazil-São Paulo-São Paulo-
Organization
Abbott Prod Oticos Ltda (7602)
Job Function
Regulatory Affairs
Requisition ID
6795190207

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