Senior Regulatory Affairs Analyst – Project Feasibility Focus

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

📋 Description

• Evaluate the scope of new projects and collaborate with the clinical research, bioequivalence, and medical information teams to establish the clinical-regulatory pathway necessary for the approval of new initiatives.

• Carry out due diligence on dossiers from international partners to assess or confirm the project's clinical-regulatory strategy and manage any identified risks.

• Offer regulatory assistance to both internal and external clients by addressing inquiries related to ANVISA regulations and requirements, as well as ensuring compliance with specific guidelines for new product registration.

• Actively engage with partners to ensure their alignment with the regulatory strategy.

• Take part in technical discussions, representing the company with professional associations during public consultations, assessing new regulatory frameworks, and addressing emerging technical requirements; evaluate the impact of new regulations and compile multidisciplinary contributions to safeguard the company's interests and manage the products under your purview, in addition to facilitating internal training and clarifying regulatory inquiries.

• Prepare strategy-related proposals for constructive dialogues with ANVISA or other regulatory authorities.

• Contribute to the development and enhancement of the area's macro-processes and workflows, encouraging technical discussions among analysts and interfacing departments to support the company's ongoing improvement.

⛳️ Requirements

• A Bachelor's degree in Pharmacy, Biochemistry, Chemistry, Biology, or Biomedicine is mandatory.

• Intermediate to advanced proficiency in English is required.

• Competence in using the Microsoft Office suite is essential.

• Demonstrated experience in project feasibility processes, particularly in defining the clinical-regulatory pathway for registration.

• Familiarity with international guidelines and standards (ICH, EMA, FDA) is required.

• Experience in registering synthetic (chemical) drugs in Brazil is essential.

🏝️ Benefits

• Meal voucher (Vale Refeição).

• Food allowance (Vale Alimentação).

• Libbs medications – 100% coverage.

• Pharmacy agreement – Vidalink.

• PPR – Company Profit Sharing Program.

• Parking, commuting allowance, or company shuttle (available only for shift work).

• USE Program: subsidy for purchasing equipment for work, which can also be utilized for personal purposes.

• Flexible benefits (TotalPass), life insurance, private pension, health insurance, dental care, and meal assistance.