Regulatory Affairs Manager - Brazil
Sao Paulo, Brazil
Our client is a global pharmaceutical company seeking to aggressively grow and launch their products in Brazil seeks a Regulatory Affairs Manager who will be responsible for meeting requirements established by the governmental agencies in Brazil for introducing new products to market and maintaining marketability in the country.
Essential Duties and Responsibilities:
· Prepare submissions for new products and product changes as required to ensure timely approvals for market release.
· Maintain product registration dossier requirements lists and communicate requirements to the Director.
· Check and review necessary documentation to be in compliance with local regulatory office/ corporate regulations
· Will control mechanisms/processes to review status of each submission for country
· Identify product changes that represent an impact to the region and distinguish when a change requires approval prior to commercialization. This includes reviewing labeling, promotional materials, product changes and documentation for changes requiring government approval.
· Close follow up of local translations, notarization and legalization.
· Assist in authorizing product release for distribution to country
· Supply documentation required for tenders/bids in the Region.
· Monitor all modifications and information regarding changes on the regulations.
· Activities of new products and/or medical devices labeling.
· Support Logistics area each time an extension of the code will be required.
· Translation of technical material when it is required.
· Join Trade Associations meetings
· May interface with distributors on projects/products as identified by the manager.
· Maintain Regulatory Affairs files to support compliance with regulatory requirements.
· Track and RA report status in region.
· Develop operating procedures to gain efficiencies.
· Travel requirements: <25%
· BA/BS degree in Pharmaceutical Sciences
· Must be fluent in English and Portuguese. Spanish is a big PLUS
· 5+ years’ experience in regulatory affairs in Pharmaceutical and Biotechnology
· Must have at least 3 years of experience in RA in Biotechnology and/or biological specimens.
· Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, and the ability to retain confidential information.
· Must be customer service oriented with strong interpersonal skills
· Excellent organizational skills and demonstrated ability to handle multiple tasks accurately and efficiently
· Prior experience in fast-paced office with multiple priorities.
· Excellent presentations skills.
· Responsive, action-oriented and innovative problem solver
· Master’s degree Biological Sciences or applicable field.
· Progressive work experience in the following areas:
· Preparing international product registration dossiers for Pharmaceutical products
· Compiling technical files
· Regulatory/clinical/product development/ quality experience
· Regulatory affairs regulations and processes
· Prior experience with Mercosur Region strongly preferred (Argentina, Bolivia, Brazil, Paraguay, Uruguay, Venezuela)
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