Regulatory Affairs Specialist

Cornerstone International Clinical is building its regulatory affairs capability and is seeking a Regulatory Affairs Specialist to support clinical study submissions and regulatory strategy across the portfolio. This role sits at the intersection of clinical development and regulatory science.

Responsibilities

• Prepare and review regulatory submissions including CTAs, IND amendments, annual reports and safety updates
• Liaise with regulatory authorities in Europe and other regions as required
• Provide regulatory guidance to project teams on study design, protocol amendments and labelling questions
• Track regulatory intelligence and update internal teams on relevant guidance documents and regulatory developments
• Support audit and inspection readiness activities

Requirements

• Degree in pharmacy, medicine, life sciences or a related field
• Minimum three years of regulatory affairs experience in a clinical development environment
• Experience with EMA submissions and familiarity with EU Clinical Trials Regulation (CTR)
• Strong attention to detail and ability to manage multiple submissions simultaneously