Job Description
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 mee...
· 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 mee...