Regulatory Affairs Associate

About the Role

This role supports regulatory activities related to global clinical development.

Key Responsibilities

• Prepare, review, and maintain regulatory documentation in line with applicable standards.
• Interpret and apply regulatory requirements.
• Support the preparation and coordination of regulatory submissions.
• Assist in ensuring ongoing regulatory compliance across projects and regions.
• Collaborate with cross-functional teams (e.g., project management, quality, clinical supply chain).
• Track regulatory changes.
• Maintain internal records and databases.
• Contribute to standard operating procedures.
• Communicate clearly with internal stakeholders and clients regarding regulatory timelines, expectations, and deliverables.

Qualifications

• Strong skills in Regulatory Documentation and Regulatory Submissions, including drafting, compiling, and reviewing clinical trial-related regulatory materials.
• Solid knowledge of Regulatory Compliance and Regulatory Requirements, with the ability to interpret guidelines and ensure adherence to relevant national and international regulations.
• Foundational expertise in Regulatory Affairs, with a demonstrated interest in clinical development and medical device or biopharmaceutical regulation.
• Strong attention to detail.
• Organizational skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• Effective written and verbal communication skills.
• Ability to work collaboratively in cross-functional teams.
• Ability to interact professionally with clients and regulatory bodies.