Manager, Global Regulatory Submissions
il y a 1 mois
As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Role Details:
The "Manager, Global Regulatory Submissions" will collaborate with peers across the organization in order to achieve client-centric delivery in a matrix organization; in particular, collaboration across all stakeholders within Site Readiness.
Please be advised that this is not a people manager position.
**Essential Job Duties**:
- Oversight and accountability for RA/IRB/EC/Third Body submissions, including submission strategy, timeline planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems
- Provides consolidated country requirements and regular status updates to project team and Client, as applicable
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests by preparing, reviewing and providing input to core study documents as applicable. This may include the compilation, review and distribution of core package, QC of core package, and country packages, maintenance and close out
- Provide the highest quality advice on regulatory issues to members of project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to RA, IRB/EC and Third Body submissions
- Review and input into required Start Up project plans. Distribute, implement and monitor compliance to Start Up project plan with respect to RA/IRB/ EC/Third Body submissions
- Ensure responsible deliverables are met within required timelines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones. Proactively identifying and escalating to Start-up Lead any risk to meeting deliverables. Manage projects according to the billing guide to ensure the work is performed within budget. Notify the Start-Up Lead of hours identified as Out-of-Scope
- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the quality of the submission work performed on assigned projects. Support audits (internal and external) and inspections, as needed. Support resolution of any findings
- Present/attend at external and internal meetings including, but not limited to: project core team and client meetings, Pre-Post Award Transition (PPAT) and Time Expectations Meetings (TEM), Kick Off Meetings (KOM)
- Contribute to the development of the group through participating and leading in process improvement initiatives, e.g. developing and updating SOPs
**Requirements (Experience, Education, Qualifications and Skills)**
- Minimum of 6-7 years’ experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development
- Excellent communication, organization and planning skills with an attention to detail
- Direct project management skills and ability to work independently
- Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations in particular
- Bachelor's degree or higher
- Fluency in English
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
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