Regulatory Affairs Associate

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

📋 Description

• Assist in the preparation and coordination of local regulatory submissions, which include MAAs and control changes, in compliance with ANVISA requirements.

• Monitor and track the status of regulatory activities submitted to local health authorities.

• Aid in the creation of module 1 documentation and other components specific to country submissions.

• Keep abreast of ANVISA regulatory updates and relay pertinent changes to internal teams.

• Support activities related to audit and inspection readiness, and facilitate timely closure of CAPA.

• Help interpret local regulations and the expectations of regulatory agencies.

• Assist in updating labeling, including SmPC, PIL, and packaging, in accordance with local regulations.

• Review promotional materials against relevant regulations and approved labeling.

• Maintain and refresh Veeva Vault with precise data concerning local regulatory activities and submissions.

• Aid in tracking compliance KPIs and regulatory milestones.

• Support local regulatory tasks linked to market authorizations, product registrations, and control changes in Brazil.

• Ensure adherence to ANVISA requirements and assist with product lifecycle management at the affiliate level.

⛳️ Requirements

• Minimum of 2–3 years of experience in regulatory affairs with direct involvement in ANVISA and Brazilian regulatory requirements.

• Experience in supporting MAAs and/or control changes.

• Understanding of labeling requirements and standards for submission documentation.

• Familiarity with Veeva Vault is preferred.

• Bachelor's degree in natural sciences, pharmacy, biology, chemistry, or a related discipline.

• Knowledge of ANVISA regulations and processes for Brazilian regulatory submissions.

• Experience with Veeva Vault or similar regulatory management systems.

• Proficient in the MS Office suite.

• Strong written and verbal communication skills in both English and Portuguese.

• Detail-oriented with a focus on accuracy in documentation.

• Good organizational skills and time management abilities.

• Capable of working effectively in a cross-functional team environment.

🏝️ Benefits

• Dedicated role with sponsorship.

• Global team atmosphere.

• Chance to contribute to therapies that benefit patients.

• Collaborate with a leading global clinical development partner.

• An advanced degree is considered a plus.

• Regulatory Affairs certification is beneficial (e.g., RAC or equivalent).