Regulatory Affairs Manager (Relocation to Cyprus)

Regulatory Affairs Manager (relocation to Cyprus)

About Us

FUICS is a state-of-the-art Biotech development company transforming pharmaceuticals from pre-clinical stage to commercial readiness.

We are looking for a motivated individual to join us as a Regulatory Affairs Manager. The job offers great potential for personal development and growth.

Job Purpose

As a Regulatory Affairs Manager, you will lead and support regulatory activities for our clinical trial programs. In this role, you will be a key strategic partner to Clinical Operations, Quality, CMC and Preclinical teams, ensuring timely and compliant regulatory submissions across multiple regions.

Responsibilities:

• Develop and execute regulatory strategies for clinical trials (Phase I–III) in alignment with global development plans.
• Prepare, review, and manage regulatory submissions including INDs, CTAs, amendments, and annual reports.
• Serve as the primary regulatory contact with health authorities (e.g., FDA, EMA, MHRA) for clinical trial matters.
• Provide regulatory guidance to cross-functional teams on trial design, protocols, and regulatory requirements.
• Track and interpret evolving regulatory guidelines and assess their impact on ongoing and planned trials.
• Ensure regulatory compliance throughout the clinical trial lifecycle, including inspection readiness.
• Contribute to internal SOPs, regulatory intelligence, and continuous process improvement initiatives.

Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field (advanced degree preferred).
• 5+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry.
• Hands-on experience with clinical trial submissions and regulatory interactions.
• Strong knowledge of ICH guidelines, GCP, and global clinical regulatory requirements.
• Experience working with multiple regions (US, EU, and/or other international markets).
• Excellent written and verbal communication skills.
• Ability to manage multiple projects in a fast-paced, collaborative environment.
• Languages: English (Greek, German or Russian would be an advantage).