Estagiário, Assuntos Regulatórios (Sao Paulo, Brazil)

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Education

Required: Graduation in progress in the Pharmacy and Biochemistry course, with active student bond throughout the internship.

General Description/Scope of Responsibilities (Internship)

Regulatory Affairs ensures the compliance of products, from registration and post-registration to the life cycle (label/package insert, variations and renewals), working with ANVISA and other competent agencies. As an intern, the position will give direct support to the routines of the area, acquiring knowledge, developing critical vision, organization and technical communication.

Essential Functions of the Internship

Prepare, organize and review technical documentation for registration and post-registration submissions (variations, renewals, label/package insert updates), following current guidelines and standards. Prepare submissions in CTD (Common Technical Document) format in electronic format according to the company's regulatory information systems. Assist in electronic petitioning and monitoring of processes with ANVISA (e.g., assembly of dossiers, protocols, fees/GRU, control of deadlines and status).

Support responses to technical requirements (compilation of evidence, file versioning, deadline control and submission). Keep databases and indicators (trackers, spreadsheets and internal systems) up to date, ensuring traceability and data integrity. Support the regulatory review of package inserts and labeling (checking of words, layouts and compliance with legislation). Contribute to the management of licenses and certifications (e.g., AFE, CBPF) and interface with local Health Surveillance when necessary.

Support regulatory processes related to the import and release of products, in partnership with Quality and Import. Monitor regulatory changes (monitoring official regulatory publications) and prepare summaries of impact on the business. Participate in the update of SOPs/SOPs and internal training in the area. Organize files and document management (versioning, nomenclature, audit trails). Track and monitor competitor products, as well as support the Regulatory Intelligence developed in the area.

Computer Skills

Microsoft Office Outlook Sharepoint Teams Adobe Acrobat Other Qualifications: Organization, planning, proactivity, attention to detail and clear written and oral communication. Intermediate or advanced English.

Travel

0% of time Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer.

BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.