Sr. Regulatory Affairs Specialist - Brazil
New York, NY US
As Regulatory Affairs Brazil for Export Countries Coordinator you will play a key role for bringing support to Regulatory Affairs Area in day-to-day activities for Health Care Business Group, in Brazil. In this role, you will be able to coordinate with the regulatory team in the Headquarter, Sources of Supplies, and local Consultants and distributors the necessary regulatory information to compile, carry out the file preparation, and coordinate the submission of dossiers with registration purposes, update registers, etc to local regulatory agencies and provide regulatory documents and certificates for local bids under Regulatory Affairs Leader supervision for export countries thus supporting the product registration activities, and the business continuity. This role will be part of the new generation of the RAQ overlooking to support the spin-off of Health Care Divison as a new Healthcare company collaborating in providing various medical solutions with technological innovation in Brazil region. Here, you will make an impact by:
You will be responsible for providing all regulatory support to Consultants and Distributors in Export Countries, in order to assure compliance with the local regulatory legislation, and the Company's requirements.
You will be the regulatory contact between the Consultants in Brazil export countries and the Regulatory team in the Headquarter, and in the different Sources of Supply in order to provide the regulatory information required locally to maintain and update sanitary registers, register new products, provide documents and certificates, etc.
You will be responsible for managing regulatory documents and providing these to Consultants and Distributors: Technical and Legal Documents of registration and bids activities such as Certificate of Foreign Government, Certificates of Free Sale, Good Manufacturing, etc.
You will be responsible of the compile, preparation, and support the submission of dossiers with regulatory purposes in Brazil countries assigned for submission of Medical Devices and Drugs
You will carry out the development of Standard Operation Procedures (SOP's) for Regulatory Activities and Tracking with the Consultants, and Distributors.
Others: Approvals of Stocks Keeping Units (SKU's) for Supply and Demand Activities. Labeling review and approvals and Advertising review for Marketing campaigns.
Your Skills and Expertise
To set you up for success in this role from day one requires (at a minimum) the following qualifications:
College: Degree in pharmaceutical, medical, or biomedical
Certificate issued is required.
English, Advanced or Medium Level to perform in a fluid way all the activities assigned as part of a bilingual community across Brazil and International stakeholders (basic requirement as part of the job profile to fulfill to this position;skill to demonstrate during the interview)
Ability to coordinate multitasks
Responsible for assuming delegation of activities and taking leadership when it's needed assigned by the Direct Supervisor/or next highest level into RAQ organization
Capacity to negotiate with internal stakeholders and external stakeholders like Consultants, Distributors, and local Regulatory Agencies.
Analytic capacity, sense of urgency, and prioritizing ability;proactively and high effectiveness for the follow-up to fulfill the assigned activities
Experience: Advanced knowledge in Regulatory Affairs and Documentation Activities for Medical Devices and /or Drugs
Good understanding of the regulatory background in market authorization applications in Medical Devices and Drugs licenses maintenance and Life Cycle Product
Additional qualifications that could help you succeed even further in this role include:
Advanced skilled technical person/team required for product registrations
Strategy independence for making regulatory basic decisions for delegated tasks
Able to anticipate regulatory barriers based on their advanced knowledge of medical device regulations and use challenges as learning opportunities to avoid making the same mistake twice
Strongest-proactive team player
Focuses work team to accomplish key strategic goals
Positively contributes to and supports team efforts and objectives.
Work location: Hybrid
Travel: May include up to 10%, international