Regulatory Submissions Lead Ii
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OverviewAs Regulatory Submissions Lead II, you steer global regulatory strategy and submissions across studies to secure approvals for novel therapies and devices.
You'll partner with cross-functional teams to manage CTAs, regulatory documents, and start-up activities, ensuring alignment with timelines and country requirements.
You'll own submission quality and regulatory content, anticipate risks, and contribute to business development through regulatory input.
This role places you at the core of medical innovation, guiding complex projects from start-up to approval.
ResponsabilidadesLead regulatory strategy and submissions across multiple regions for complex studies
Coordinate and submit CTAs and regulatory applications, including ethics and competent authorities
Own EU CTIS activities and develop overall submission strategy for Part I
Prepare and secure approval of core submission documents (forms, cover letters, PIF/ICF)
Review regulatory documents (IMPDS, ICH, IBs, consent forms, labels) for compliance and quality
Drive start-up readiness, define Greenlight templates, and coordinate site activation
Ensure regulatory excellence, budget oversight, and process improvement
Provide senior-level expertise, coaching, and leadership across regulatory domains
Requisitos principales8-10 years in regulatory submissions or related roles
at least 6 years in a lead/submissions management capacity
experience with complex trials and global submissions
experience with MD/IVDR and GMO is highly recommended
excellent knowledge of ICH/GCP, FDA/EU regulations, ISO*
strong team collaboration, multitasking, and deadline-driven organization
customer service oriented and accountable for quality
team player
collaborative
strong communication
CTIS hands-on experience
regulatory submissions management
start-up readiness and Greenlight processes
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