Submissions & Reg. Intelligence Manager

What you'll do

• Provide expert guidance on clinical study data regulatory submission requirements and strategies.
• Ensure consistency of clinical data standards across clinical trials in compliance with regulatory requirements.
• Act as the primary point of contact for stakeholders regarding data management and global regulatory affairs.
• Maintain deep expertise in Regulatory Health Authority guidance and industry standards like SDTM and ADaM.
• Manage standards, projects, and processes for the Clinical Data Standards organization.
• Coach and train junior colleagues on clinical data standards applications and responsibilities.
• Support the design and integration of new technologies to enhance clinical data standards.
• Lead the Submission Center of Excellence to ensure trial-level submission readiness post-database lock.

What we're looking for

• A Bachelor’s degree in a scientific, technology, or healthcare discipline, or equivalent experience.
• Advanced degrees such as a Master or PhD (preferred).
• At least 6 years of relevant pharmaceutical or scientific experience in data management, biostatistics, clinical, or statistical programming.
• Expert knowledge of relevant regulatory requirements such as GCP and ICH.
• Expert knowledge of industry standards such as SDTM and ADaM.
• Experience with regulatory submissions such as NDA and BLA (preferred).
• Demonstrated written and verbal communication skills in English.
• Demonstrated leadership on cross-functional projects and in decision making and problem solving.