Regulatory Affairs Analyst – Start-Up

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Respond to sponsor inquiries with the necessary detail and support them with relevant current legislation.

• Engage in discussions to determine the optimal strategy for various projects.

• Identify potential risks and opportunities for projects as applicable legislation and/or requirements evolve.

• Take part in conversations to select the most effective strategy for projects involving clinical research and products.

• Conduct technical reviews of documents prior to regulatory submission.

• Prepare and assess documents, including compiling clinical research dossiers and submissions for various product categories to ANVISA.

• Perform thorough reviews of technical dossiers for product registration and post-registration purposes in Brazil.

• Assist in defining and deliberating the clinical development plan for investigational products.

• Revise documents as needed following feedback from involved parties in the project.

• Contribute to technical responses to requirements from competent authorities.

• Organize research project documents following internal procedures.

• Maintain the project database in accordance with internal guidelines.

• Review Standard Operating Procedures (SOPs) relevant to the department.

• Monitor publications of interest to the company and/or sponsors in the Official Gazette of the Union.

• Participate in Regulatory and Scientific Affairs meetings and other meetings upon request.

• Join technical meetings with sponsors and regulatory authorities alongside the Regulatory Affairs and Start-Up Management team when needed.

• Stay updated with regulations and applicable technical requirements established by the Brazilian regulatory agency, along with international guidelines for project planning, execution, and submission.

• Engage in specific technical groups of organizations when the topic significantly impacts the company and/or sponsors.

⛳️ Requirements

• Bachelor’s degree in Pharmacy.

• Preferred: Postgraduate degree in Regulatory Affairs, Health Surveillance, or a related field.

• Prior experience in Regulatory Affairs, ideally within the pharmaceutical industry, a CRO, or consulting.

• Experience with submissions and protocols to ANVISA.

• Knowledge of Brazilian health regulations (ANVISA), including RDCs governing registration, post-registration, bioequivalence/bioavailability studies, clinical research, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and pharmacovigilance.

• Familiarity with international regulations and guidelines, such as FDA and ICH, is preferred.

• Strong technical and scientific writing abilities, demonstrating clarity and precision.

• Exceptional organizational skills, attention to detail, and capacity to meet deadlines.

• Advanced proficiency in Microsoft Office (Word, Excel, and PowerPoint).

• Preferred: Familiarity with AI tools used for drafting, reviewing, and verifying regulatory documents, with the ability to critically validate generated results.

• Analytical skills and a critical approach to document review.

• Capability to work collaboratively and communicate effectively with internal departments and regulatory authorities.

• Advanced English proficiency.

• Intermediate Spanish proficiency.

🏝️ Benefits

• Transportation allowance.

• Parking (subject to availability).

• Health insurance with no monthly premium for employees; co-payments apply to examinations and consultations.

• Dental insurance with a monthly premium co-payment.

• Life insurance at no cost to employees.

• Flexible meal and food allowance.

• Pharmacy benefit program.

• Flexible time bank for holidays and commemorative dates (in accordance with internal policy).

• SESC partnership.

• Physical wellness program – TotalPass.

• Day off for healthcare professionals.

• Childcare assistance (in accordance with internal policy).