Submissions & Regulatory Intelligence Manager

About the role

The Submissions & Regulatory Intelligence Manager will lead the Clinical Data Standards strategy within Integrated Data Analytics & Reporting, ensuring consistency of clinical data across trials and compliance with regulatory requirements.

Key responsibilities

• Provide expert guidance on regulatory submission requirements and develop tailored solutions for IDAR projects.
• Act as the single point of contact for data management, clinical programming, and global regulatory affairs teams.
• Maintain deep expertise in health authority guidance, SDTM/ADaM packages, and support the Submission Center of Excellence.

Required profile

• At least 6 years of experience in pharmaceutical data management, biostatistics, or clinical programming.
• Strong knowledge of regulatory requirements (GCP, ICH) and industry standards (SDTM, ADaM).
• Excellent written and verbal communication skills in English.

Required skills

• SDTM and ADaM submission packages
• GCP and ICH guidelines
• Regulatory submission processes (NDA, BLA)

What we offer

• Competitive salary with annual bonus based on performance.
• Flexible hybrid work model (3 days onsite per week).
• Comprehensive health and well‑being benefits and career development opportunities.