Regulatory Affairs Associate - FSP

Accountabilities

• Support the preparation, coordination, and submission of local regulatory applications, including Market Authorization Applications (MAAs), product registrations, and control changes, in accordance with ANVISA requirements.

• Track and monitor regulatory submissions and follow up on their progress with local health authorities.

• Assist in preparing Module 1 documentation and other country-specific submission components.

• Monitor ANVISA regulatory updates, interpret relevant requirements, and communicate changes to internal stakeholders.

• Support audit and inspection readiness activities and contribute to the timely closure of Corrective and Preventive Actions (CAPAs).

• Assist with product labeling updates, including Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and packaging materials, ensuring alignment with local requirements.

• Support the review of promotional materials to verify compliance with applicable regulations and approved product labeling.

• Maintain accurate regulatory records and submission information in Veeva Vault or equivalent systems.

• Help monitor regulatory compliance KPIs, submission timelines, and key milestones.

Requirements:

• 2–3 years of experience in Regulatory Affairs, with direct exposure to ANVISA and Brazilian regulatory requirements.

• Practical experience supporting Market Authorization Applications (MAAs) and/or regulatory control changes.

• Knowledge of Brazilian regulatory submission processes, local labeling requirements, and submission documentation standards.

• Familiarity with Veeva Vault or similar regulatory information management systems; Veeva Vault experience is preferred.

• Bachelor's degree in Pharmacy, Biology, Chemistry, Natural Sciences, or a related field.

• An advanced degree is an advantage.

• Regulatory Affairs certification, such as RAC or an equivalent qualification, is a plus.

• Advanced or fluent English, with strong written and verbal communication skills in both English and Portuguese.

• Proficiency in Microsoft Office applications.

• Excellent attention to detail and accuracy when preparing and maintaining regulatory documentation.

• Strong organizational and time-management skills, with the ability to manage multiple activities and deadlines.

• Ability to collaborate effectively with cross-functional teams and communicate regulatory information clearly.

Benefits:

• Remote work model based in Brazil.

• Full-time, sponsor-dedicated opportunity.

• Exposure to local regulatory submissions, product lifecycle management, and Brazilian pharmaceutical regulations.

• Opportunity to contribute to regulatory compliance and the development and availability of therapies that benefit patients.

• The source does not specify salary, healthcare coverage, or additional benefits.