Clinical Subject Matter Expert

Job Title: Clinical Subject Matter Expert– Gap Analysis Report Preparation

Location: Bulgaria, Greece, or Czech Republic (Remote)

Contract Duration: 27 July 2026 - 21 August 2026

Company Overview

Apsida Life Science is partnering with a leading global clinical research organization that supports pharmaceutical, biotechnology, and medical device companies throughout the product development lifecycle. The organization provides end-to-end services across clinical research, regulatory consulting, market access, pharmacovigilance, medical communications, and commercialization.

Key Responsibilities:

• Review available clinical and regulatory documentation.
• Assess two potential regulatory pathways for product registration.
• Evaluate whether existing clinical data are sufficient to support registration.
• Identify any clinical data gaps and recommend additional evidence where required.
• Review and assess the suitability of the proposed regulatory strategy, providing alternative recommendations where appropriate.
• Support the development of strategies for any required clinical studies, including: guidance on study protocols and assessment of regulatory acceptability.
• Prepare a comprehensive gap analysis report detailing:
• Findings and rationale.
• Recommendations.
• Potential registration pathways.

Requirements:

• Advanced degree in Medicine, Pharmacy, Clinical Pharmacology, Life Sciences, or a related discipline.
• Significant experience in clinical development and regulatory strategy for medicinal products.
• Strong understanding of local regulatory requirements in Bulgaria, Greece, or the Czech Republic.
• Experience supporting marketing authorization applications and regulatory submissions.
• Demonstrated experience conducting clinical gap analyses and evaluating clinical evidence.
• Familiarity with prolonged-release formulations and regulatory requirements for variations or new registrations is advantageous.
• Excellent analytical, technical writing, and communication skills.

If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science:

[email protected]

+44 744 134 1041

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.