Senior Regulatory Affairs Analyst – Pricing Strategy

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

📋 Description

• Evaluate new projects from a regulatory pricing standpoint, identifying potential risks, opportunities, and their impacts on feasibility.

• Analyze clinical evidence, therapeutic advantages, innovation, patient demographics, dosage regimens, indications, and product differentiators to formulate pricing justifications.

• Suggest relevant price categories, comparators, and regulatory scenarios for new projects.

• Assess treatment expenses, international pricing, and references necessary for developing pricing justifications.

• Prepare and review the Price Information Document along with other technical documents for submission to CMED.

• Monitor requirements, reconsideration requests, appeals, and technical discussions related to pricing procedures.

• Keep track of regulatory changes impacting pricing and evaluate their effects on projects in development.

• Collaborate effectively with Clinical Research, Medical and Scientific Evidence, Development, New Business, Medical Advisors, Marketing, Market Intelligence, and corporate functions.

• Contribute to enhancing internal processes associated with the evaluation and pricing of new products.

⛳️ Requirements

• Bachelor’s degree in Pharmacy, Biomedicine, Biological Sciences, or a related healthcare discipline.

• Experience with new projects, regulatory feasibility assessments, drug registration, or similar activities.

• Proficiency in analyzing scientific literature, clinical data, and technical and regulatory information.

• Understanding of drug development and registration processes.

• Intermediate proficiency in English.

• Experience with drug pricing or processes related to CMED.

• Experience in preparing Price Information Documents.

• Familiarity with price categories, comparators, treatment costs, and international references.

• Experience with innovative medicines, biologics, biosimilars, or highly complex products.

• Knowledge of pharmacoeconomics, health economics, or health technology assessment.

🏝️ Benefits

• Meal voucher

• Food allowance

• 100% coverage of Libbs medications

• Pharmacy benefit through Vidalink

• Profit-Sharing and Results Program

• Parking, transportation allowance, or company shuttle

• USE Program: subsidy for the purchase of work-related equipment that may also be used for personal purposes

• Flexible benefits (TotalPass, life insurance, private pension plan, medical and dental insurance, and food allowance)