Regulatory lcm associate scientist – São Paulo/SP

SP | São Paulo
Efetivo (CLT)
Biólogo
Bioquímico
Farmacêutico
Químico

Principais atividades

• Coordinate Regulatory Life Cycle Management activities within Digestive Brands Franchise.
• Coordinate with Local Regulatory Affairs for roll outs (expansions to white space), variations, renewals and answering health authority requests.
• Coordinate as RA SPOC all regional and global projects related with his/her products of responsibility. Elaborate and implement regulatory assessments to support those projects requirements and assure portfolio in place.
• Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve registrations for the specific product portfolio.
• Ensure regulatory assessments are conducted for change controls in the respective Quality tracking system.
• Advise organization of potential regulatory risks in normal day to day activities and proactively recommend the regulatory mitigation actions required.
• Provide Regulatory input for Periodic Safety Update Reports (PSURs), Periodic Quality Reports (PQRs), and Product Data Sheets (PDS).
• Liaise with Corporate Technical and Product Supply functions to provide the current registered details.
• Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents.
• Provide regulatory input into Global Product labelling and approval to enable commercial activation of product launches in compliance with local market regulations.

Qualificações

• A minimum of Scientific bachelor’s degree in Life-Science (pharmacy, medicine, chemistry, biology, etc.).
• Proficiency in English, Spanish.
• Regulatory experience (1-3 years) preferably in consumer health and preferably across multiple regulatory classification areas (food supplements, medicines, medical devices, etc.)
• Some experience in maintenance of existing products licenses across one or, ideally, more than one different Latin America countries.
• Some experience in developing regulatory strategies for successful launches of new products.
• Demonstrated ability to work independently in a matrix environment to build superior relationships with stakeholders.
• Strong initiative and follow-through with accountability for work quality.
• Excellent attention to detail, communication and presentation skills.
• Results oriented and self-motivating with an ability to influence others.
• Demonstrated ability to handle competing priorities effectively with excellent organizational skills.
• Commercial understanding of corporate and operational business issues.
• Openness to change and ability to think out of the box.