Senior Regulatory Compliance Manager

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$60.000 - R$90.000

Regulatory Affairs Lead Specialist

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This role involves coordinating and ensuring the proper submission and approval of various medical devices or other categories of products to government regulatory agencies, while organizing and balancing a multitude of projects simultaneously.

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- Coordinates the work of RA Specialists to ensure submission is done properly and in timely manner
- Selects and manages external consulting services to prepare files in same conditions than internal as needed
- Supports regional team on product submissions schedules, prioritization, and pipeline management.
- Supports regional team on requests and follow-up of documentation provided by OCs to prepare registration dossiers
- Act as liaison for franchises to support business plans and regulatory needs
- Serves as a technical expert within job function
- Prepare and lead training for RA Specialists
- Propose innovative strategies/solutions for technical files and submission to fulfill requirements and be in compliance with regulatory agency requirements
- Participate in multifunctional teams to establish regulatory strategic plans with minimal guidance
- Assist in the development and implementation of regulatory strategies with team representatives and with the Regulatory Affairs Manager.
- Prepare and submit proper regulatory documents and technical files to MoH with minimal supervision
- Prepare alert communications according to registration process progress and findings during this
- Lead specific projects/requests to ensure alignment with business goals and timely responses
- Coordinate information on several projects simultaneously
- Interacts with other personnel, government agencies in a professional, decisive, & articulate manner.
- Scan and influence the external environment.
- Represent at Local MoH meetings and external organizations
- Provide assistance with establishment registration licenses.
- Coordinate/assist in the review and analysis of market licenses and labeling to set up product codes status
- Ensure that Regulatory Databases and Labeling Databases are well updated as per submissions and approvals received
- May identify and communicate new regulatory/legal requirements
- Support franchise, bids and functional areas consultations to clarify regulatory questions/conditions
- Actively participates and timely delivery results in RA teams to achieve common goals or attend common strategies
- Adhere to company and regulatory bodies' policies and procedures regarding product introductions, changes and labeling
Support to review promotional materials according to current product registration and MOH regulation

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