Regulatory Affairs Coordinator

Job Description

Join our team as a Regulatory Affairs Coordinator, where you will ensure compliance with local and international regulations. You will be responsible for preparing and submitting documentation, liaising with regulatory authorities, and supporting the successful launch of our innovative products into the market.

Responsibilities

• Draft and manage submissions to regulatory bodies.
• Ensure that all product labels and promotional materials comply with regulations.
• Assist in training staff on compliance-related topics.
• Track project timelines and ensure timely submission of documentation.
• Provide support during inspections and audits by regulatory agencies.
• Compile and review data for regulatory submissions to enhance approval success.

Requirements

Education

• Master's degree in a relevant field is preferred

Experience

• 3-5 years of experience in regulatory affairs or related sectors

Technical Skills

• Regulatory Strategy Development
• Risk Assessment

Soft Skills

• Strategic Thinking
• Problem Solving

Languages

• English: Fluent

Advantageous

• Experience with FDA/EMA regulations: Familiarity with the submission processes for FDA and EMA.
• Proficiency in Regulatory Software: Experience with regulatory software tools for managing submissions.

Benefits

• Competitive salary package
• Health and life insurance
• Flexible working conditions
• Professional development opportunities

Company Culture

• Integrity: We maintain the highest integrity in all our dealings and ensure transparency in our processes.
• Innovation: We encourage innovative thinking to solve regulatory challenges.
• Collaboration: Our team thrives on collaboration, sharing knowledge and best practices.