Job Title: Specialist, Regulatory Affairs Strategy

Location: Barcelona, Spain (hybrid)

Key Responsibilities

• Creating and managing clinical trial regulatory strategy for biologics, executing clinical trial regulatory activities in alignment with agreed clinical timelines, including responses to health authority queries, amendments to clinical trial dossiers, regulatory SUSAR reporting, or any other regulatory activities as needed.
• Oversight of clinical trial regulatory submissions, ensuring accurate and compliant dossiers.
• Archiving clinical trial documentation.
• Managing health authority interaction for assigned regions in alignment with the agreed regulatory strategy.
• Identifying and assessing risks associated with the clinical regulatory submissions and recommending strategies to mitigate these risks.
• Providing regular updates to global regulatory lead and indication regulatory leads regarding specific clin...