Expertise in eu ctr, fda ind, health canada pathways
The role involves serving as a Regulatory Team Lead on complex global studies with oversight of technical writing and submission publishing
Job Summary
The role involves serving as a Regulatory Team Lead on complex global studies with oversight of technical writing and submission publishing.
Candidates must engage directly with clients and Competent Authorities across multiple regions to clarify regulatory pathways and address feedback.
The position requires monitoring scope, deliverables, timelines, and budget while providing guidance to junior colleagues and supporting training initiatives.
Matching Summary
The role involves serving as a Regulatory Team Lead on complex global studies with oversight of technical writing and submission publishing.
Skills & Requirements
Must-have
3-4 years clinical trial regulatory experience
Bachelor's or Master's degree in Life Sciences
Expertise in EU CTR, FDA IND, Health Canada pathways
Proficiency with eCTD systems and Microsoft Office
Experience drafting and quality-checking core study documentation
Nice-to-have
Biotech therapy area exposure welcomed
Experience with LATAM or APAC regions
Strong stakeholder management abilities
Problem-solving mindset in fast-paced environments
Ability to present at full-service bid defenses
Key Requirements
3–4 years relevant clinical trial regulatory experience
Bachelor's or Master's degree in Life Sciences
Demonstrated expertise in at least one clinical trial regulatory domain