Senior Regulatory Affairs Associate

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

📋 Description

• Serve as the Local Regulatory Contact (LRC) and manage the preparation and submission of clinical trials via the REPEC Platform in Peru.

• Dedicate 50% of your daily efforts as the Global Regulatory Lead for designated global projects, offering strategic direction and coordination.

• Create country-specific labels and assess LATAM labels for regulatory adherence and uniformity.

• Provide both verbal and written communications regarding regulatory strategy to global sponsors, customizing recommendations to meet country-specific criteria.

• Sustain and refresh the Trial Master File (TMF) in Veeva Vault with study-related documents and essential milestone dates.

• Keep project management tools updated, including budget monitoring and quality issue (QI) tracking.

⛳️ Requirements

• A minimum of 5+ years of professional experience in clinical trial regulatory affairs.

• Demonstrated expertise in preparing and submitting clinical trial dossiers to the Ministry of Health (MOH) in Peru, including the review of Annex 05 and completion of Annex 33.

• Proven experience in preparing and submitting clinical trial dossiers in other LATAM countries.

• Proficient in Veeva Vault or a similar document management system.

• Familiarity with regulatory requirements in APAC or EU regions (nice to have).

🏝️ Benefits

• Join a global clinical research organization at the cutting edge of innovation.

• Work alongside international teams and sponsors on significant clinical trials.

• Enhance your regulatory knowledge in a nurturing, growth-focused environment.

• Contribute to making a meaningful impact by helping to introduce new therapies to patients.