Regulatory Affairs Lead Specialist

4 semanas atrás

São Paulo, São Paulo, Brasil Johnson & Johnson Family of Companies Tempo inteiro
Coordinates and ensures proper submission and approvals of various medical device or other categories of products to government regulatory agencies, organizing and balancing a multitude of projects simultaneously.
- 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 mínimal 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 mínimal 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 JJ personnel, government agencies in a professional, decisive, & articulate manner.
- Scan and influence the external environment.
- Represent J&J 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 participation 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
**Qualifications**
Must have at least 4 years of experience working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for complex devices and a successful track record.
Desirable experience in Medical Devices, Pharma background is acceptable.
A Bachelor's Degree in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience.
Experience with people management is desirable.
Education in Engineering or Biomedicine is desirable
Knowledge of Local & International Regulation and Processes
Advanced Degree preferred.
Bi-lingual: Fluent English - local language (Portuguese)
Advanced PC skills
**Primary Location**
Brazil-São Paulo-São Paulo
- **Organization**
J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206015447W

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