Regulatory Affairs Analyst

Description

Job Opening \| Regulatory Affairs Analyst São Paulo/SP – South Zone CLT Employment Model \| Hybrid Work Format Pinex is seeking a Regulatory Affairs Analyst to work on Patient Access Programs, supporting strategic regulatory processes and ensuring compliance with current legislation and ANVISA guidelines. The professional will directly handle programs regulated by RDC 38/2013, including: * **PTA (Post-Study Access Program):** supply of medication after completion of the clinical study; * **EAP (Expanded Access Program):** expanded access programs; * **CUP (Compassionate Use Program):** compassionate use. The role entails preparing, tracking, and maintaining regulatory submissions, as well as supporting internal departments involved in the execution of special access drug programs. **Direct Reporting To:** Regulatory Affairs Manager Key Responsibilities * Support the full lifecycle of regulatory submissions related to Patient Access Programs, per RDC 38/2013 and other applicable regulations; * Assist with pharmacovigilance activities associated with patient access programs; * Draft, review, and maintain up-to-date regulatory dossiers and supporting documentation; * Collaborate with ANVISA and other internal stakeholders to monitor regulatory processes and clarify regulatory requirements; * Monitor national and international regulatory updates related to access programs; * Ensure compliance with legal, ethical, and compliance requirements; * Support internal Pinex departments—including International Trade, Logistics, Customer Service, and Procurement—in the operational execution of access programs. Requirements * Bachelor’s degree in Pharmacy, Biomedicine, or related health sciences; * Prior experience in Regulatory Affairs, preferably in the pharmaceutical sector, or experience in Clinical Research; * Knowledge of ANVISA regulations, especially RDC 38/2013; * Experience drafting and tracking regulatory submissions; * Organized, analytical profile with strong attention to detail and effective interpersonal communication skills; * Fluent English for reading, writing, and technical communication; * Spanish proficiency is considered a plus. Preferred Qualifications * Prior experience with Access Programs (PTA, CUP, and EAP); * Knowledge of pharmacovigilance and Good Regulatory Practices; * Experience in a multinational environment or collaboration with global teams. What We Offer * A collaborative, innovative, and patient-centered work environment; * Opportunity to contribute to high-impact scientific and social projects; * Competitive compensation and benefits package aligned with market standards.