Associate, Regulatory Affairs

About the Role

This role involves preparing, reviewing, and maintaining regulatory documentation in alignment with applicable guidelines and company procedures. The associate will assist in compiling and coordinating regulatory submissions, tracking timelines, and ensuring that regulatory requirements are met for different regions and authorities. Day-to-day tasks include liaising with cross-functional teams, gathering and organizing data for regulatory filings, and contributing to regulatory compliance initiatives. The role also includes monitoring changes in regulatory frameworks, updating internal stakeholders, and supporting audits or inspections related to regulatory affairs.

Key Responsibilities

• Preparing, reviewing, and maintaining regulatory documentation.
• Assisting in compiling and coordinating regulatory submissions.
• Tracking timelines for regulatory submissions.
• Ensuring regulatory requirements are met for different regions and authorities.
• Liaising with cross-functional teams.
• Gathering and organizing data for regulatory filings.
• Contributing to regulatory compliance initiatives.
• Monitoring changes in regulatory frameworks.
• Updating internal stakeholders.
• Supporting audits or inspections related to regulatory affairs.

Requirements & Tech Stack

• Regulatory Documentation and preparation of high-quality regulatory records and files.
• Regulatory Compliance and ability to support adherence to international and local regulations.
• Regulatory Requirements and capacity to interpret and apply guidance from health authorities.
• Experience or interest in Regulatory Affairs and involvement in regulatory operations within clinical development.
• Ability to assist with Regulatory Submissions, including compiling, organizing, and formatting submission packages.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related discipline.
• Strong attention to detail.
• Organizational skills.
• Ability to manage multiple tasks and deadlines remotely.
• Effective written and verbal communication skills.
• Ability to collaborate with cross-functional, global teams.