Johnson & Johnson Carreiras

REGULATORY AFFAIRS SR SPECIALIST (Medical Devices)

São Paulo, Brasil
Regulatory Affairs


Descrição da Vaga

Requisition ID: 2620180204

*Important: We have 2 Regulatory Affairs Sr Specialist positions.

Job Summary: Coordinates and ensures proper submission and approvals for market licenses including pipeline, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously.

Scope: 
Number of Direct/Indirect Reports: May manage contractors/consultants.
Travel %: 0-5%
Reports to: RA Manager.

Major Roles and Responsibilities:
 
• Coordinate and ensure registration pipeline/changes and renewals program submission is done in timely manner.
• Participate in teams to establish and execute regulatory strategic plans with minimal guidance.
• Prepare and submit proper regulatory documents and technical files to MoH with minimal supervision.
• Provide assistance with establishment registration licenses.
• Contribute to introduce new /modified products/ extension line & others.
• Manage and track regulatory projects/requests to ensure alignment with business goals and timely responses.
• Prepare alert communications according to registration process progress and findings during this.
• Coordinate information on several projects simultaneously.
• Supports regional team on product submissions schedules, prioritization and pipeline management.
• Interacts with other JJ personnel, government agencies in a professional, decisive, & articulate manner.
• Act as liaison for assigned franchises to support business plans and regulatory needs.
• Request and follow-up documentation from OCs to prepare registration dossiers.
• Review and analyze market licenses and labeling to set up product codes status. 
• Ensure that Registered Codes Database, Labeling Database and Scanned Registers are well updated as per 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.
• Scan and influence the external environment.
• Propose innovative strategies/solutions for technical files and submission to fulfill requirements and be in compliance with regulatory agency requirements. 
• Select and manage external consulting services to prepare files in same conditions than internal as needed. 
• Assist in the development and implementation of regulatory strategies with team representatives and with the Regulatory Affairs Manager.
• Prepare and lead training for RA Specialists and Associates.
• Serves as a technical expert within job function.
• Represent J&J at Local MoH meetings and external organizations.
• Lead specific projects according to local needs.
• Company responsible person in countries where required.

Qualificações
Competencies:

• Knowledge of Local & International Regulation and Processes
• Analytical capability.
• Solid Problem Solving - sorting through ambiguity to design solution plans; creative and compliant solutions to day to day issues.
• Prioritizes work to meet deadlines.
• Communicates clearly, succinctly and effectively. 
• Planning and Organizing skills. 
• Understands the importance of the adherence to compliance
• Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.

Experience Requirements:

• Must have 3-4 years experience at least 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. Advanced Degree preferred.
• Bi-lingual: Fluent English – local language (Spanish or Portuguese).
• Advanced PC skills.


Local Principal
Brasil-São Paulo-São Paulo
Organização
J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)
Cargo
Regulatory Affairs
Requisition ID
2620180204