Descrição da Vaga
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
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
• Interacts with other JJ personnel, government agencies in a professional,
decisive, & articulate manner.
• Act as liaison for assigned franchises to support business plans and
• Request and follow-up documentation from OCs to prepare registration
• Review and analyze market licenses and labeling to set up product codes
• 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
• 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.
• 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.
• 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 (Portuguese).
• Advanced PC skills.