Key Responsibilities

· Serve as Regulatory Team Lead on complex global studies, including oversight of technical writing and submission publishing.

· Draft, review, and quality-check clinical trial regulatory core study documentation at global and country level .

· Engage directly with clients to clarify clinical trial regulatory pathways, share lessons learned, and address feedback.

· Engage with Competent Authorities in countries across multiple regions, as part of the clinical trial regulatory strategy for complex global studies

· Monitor scope, deliverables, timelines, and budget; proactively mitigate risks and escalate issues as needed.

· Provide guidance and feedback to junior colleagues; support training and continuous improvement initiatives.

· Contribute to internal SOP reviews and present regulatory processes at full-service bid defenses.

· Perform additional tasks assigned by Regulatory management to meet program goals.