Regulatory Affairs Manager

Position Overview

We are seeking a Regulatory Affairs Manager to oversee and enhance our regulatory activities, ensuring seamless compliance with EU filing requirements and supporting our business goals.

About the Role

As a Regulatory Affairs Manager, you will play a pivotal role in managing the Regulatory Affairs team and ensuring the successful preparation, submission, and management of regulatory documentation. You will be responsible for maintaining compliance, facilitating cross-functional collaboration, and driving strategic regulatory initiatives.

Key Responsibilities

• Lead the Regulatory Affairs team to meet company objectives and regulatory requirements.
• Oversee the preparation, submission, and tracking of EU regulatory filings, including technical documentation, amendments, and reports.
• Ensure compliance with applicable EU regulations and guidelines.
• Maintain a robust system for indexing and archiving technical documentation and correspondence.
• Collaborate with internal departments and external stakeholders to ensure timely and accurate submissions to competent authorities.
• Monitor changes in regulatory requirements and provide strategic guidance to adapt processes accordingly.
• Support cross-functional teams in addressing regulatory challenges and fostering compliance awareness across the organization.

Candidate Profile

• Education: Master’s Degree in Life Sciences.
• Experience: Minimum of 13 years of proven experience in Regulatory Affairs (RA), including team leadership or mentorship.
• Skills:
• Exceptional written and verbal communication skills to effectively convey complex scientific and medical information.
• Strong leadership and collaboration abilities with a proactive approach to problem-solving.
• Attention to detail and ability to manage multiple priorities effectively.

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.