Regulatory Affairs and Start Up Analyst

To join our team, we are looking for professionals who want to contribute to our mission of improving the lives of more and more people. If you have an innovative profile, think outside the box, and like to work in a modern and dynamic environment, this vacancy is for you. Come join us on this journey. #VemSerSynvia

Responsibilities and duties

We count on you to:

• Handle sponsor demands with the required detail and based on current legislation;
• Participate in discussions to define the best strategy for different projects;
• Identify eventual risks/opportunities for projects when there is a change in legislation and/or applicable requirements;
• Participate in discussions to elect the best strategy for different projects (clinical research and products);
• Technically analyze documents before their regulatory submission;
• Prepare and review documents, including the assembly of clinical research dossiers and dossiers for different product categories for submission to Anvisa;
• Perform critical analysis of technical dossiers for registration and post-registration purposes in Brazil;
• Assist in the design and discussion of the clinical development plan for an experimental product;
• Adapt prepared documents, when necessary, after review by the parties involved in the project;
• Contribute to technical responses to requirements issued by competent bodies;
• Archive research project documents according to internal procedures;
• Keep the project database updated according to internal procedures;
• Review Standard Operating Procedures relevant to the department;
• Monitor publications of interest to the company and/or sponsors in the Diário Oficial da União;
• Participate in Regulatory and Scientific Affairs meetings and whenever requested;
• Participate in technical meetings with sponsors and regulatory bodies alongside the Regulatory Affairs and Start Up Management, when necessary;
• Stay updated regarding regulations and technical requirements applicable to the Brazilian regulatory agency and international guides for planning, conducting, and submitting projects;
• Participate in specific technical groups of entities when the topic is of great impact for the company and/or sponsors.

Requirements and qualifications

What we are looking for:

• Completed Higher Education in Pharmacy;
• Differential: postgraduate degree in Regulatory Affairs, Sanitary Surveillance, or a related area;
• Previous experience in Regulatory Affairs, preferably in the pharmaceutical industry, CRO, or consultancy;
• Experience in submissions and protocols with ANVISA;
• Knowledge of Brazilian sanitary legislation (ANVISA): RDCs for registration, post-registration, bioequivalence/bioavailability studies, clinical research, good practices (BPF/BPC), pharmacovigilance;
• Desirable knowledge of international standards: e.g., FDA and ICH;
• Technical and scientific writing skills (clarity and precision);
• Organization, attention to detail, and meeting deadlines;
• Advanced Office Package (Word, Excel, PowerPoint);
• Differential: Familiarity with Artificial Intelligence tools applied to the drafting, reviewing, and checking of regulatory documents, with the ability to critically validate the generated results;
• Analytical capacity and critical vision of documents;
• Teamwork and communication with internal areas and regulatory bodies;
• Advanced English;
• Intermediate Spanish.

Additional information

Work unit: Paulínia/SP. / Remote

Work schedule: Mon/Fri - 08:00 to 17:00

What we offer in benefits:

• Vale Transporte;
• Parking (subject to availability);
• Health Plan with no monthly cost to the employee, with co-participation for exams and consultations;
• Dental Plan with monthly co-participation;
• Life Insurance at no cost to the employee;
• Flexible food/meal voucher;
• Pharmacy Agreement;
• Flexible Time Bank – holidays and commemorative dates (according to internal policy);
• SESC Partnership;
• Physical health program - TotalPass;
• Day Off – Health Professional;
• Daycare Allowance (according to internal policy).