Regulatory Affairs Specialist

Position Overview

We are seeking a Regulatory Affairs Specialist to support our regulatory activities and contribute to the success of our team.

About the Role

As a Regulatory Affairs Specialist, you will play a crucial role in preparing, submitting, and managing regulatory documentation to ensure compliance with EU filing requirements. You will collaborate closely with regulatory teams and maintain organized systems for document management, helping to drive efficiency and accuracy in regulatory submissions.

Key Responsibilities

• Prepare, submit, and track regulatory documents for EU filings, including technical documentation, amendments, and supplements.
• Maintain an organized system for indexing and archiving regulatory documentation and correspondence.
• Collaborate with internal regulatory teams to ensure timely and accurate submissions to competent authorities.
• Stay informed on changes in regulatory requirements and provide input to ensure documentation remains compliant.

Candidate Profile

• Education: Master’s degree in Life Sciences.
• Experience: Minimum 3 years of proven experience in Regulatory Affairs (RA).
• Skills:
• Strong written and verbal communication skills to convey complex technical, scientific, and medical information clearly.
• A team-oriented mindset with excellent collaboration and interpersonal skills.
• Attention to detail and the ability to manage multiple tasks effectively.
• Candidate must possess a valid work permit.

Benefits

• Competitive remuneration package with reviews and salary progression.
• Continuous professional development opportunities in a state-of-the-art, brand-new pharmaceutical facility.
• Comprehensive health insurance.