Regulatory CTA Manager
- Experience Level
This Global Pharmaceutical company is seeking a Regulatory Affairs Contractor to join them on a 12 months basis as a Regulatory CTA Submissions Manager. You will be responsible for providing leadership and expertise in the execution of Regulatory (Clinical Trial Applications) CTA submissions to regional partners and Health Authorities as well as contributing business lines to lead operational submissions execution for designated CTAs. The role occupier will operate as the CTA Subject Matter Expert and drive the submissions team to deliver Globally compliant submission-ready components. The responsibilities of this role include:
- Drive global submission management activities for assigned products and support/ lead global team efforts to ensure high quality components and submissions
- Be a key participant of development teams and relevant meetings to advocate deliverable timelines, project strategy and assess the global submissions delivery activities.
- Liaise with study management regarding essential core documents that cross both Health Authority and Ethics Committee submissions
- Act as Subject Matter Expert for Regulatory Operations and provide country-level intelligence on Clinical Trial Regulatory.
The required skills and experience for this role include:
- Exceptional managerial skills: Leadership and problem solving; juggling of multiple complex projects simultaneously; attention to detail and a strong knowledge of drug development process.
- Thorough experience with systems and electronic technologies used to support submission and planning activities.
- Demonstratable understanding of regional and national regulator filing guidelines and dossier requirements
- Robust organizational management skills
- Ability to quickly and decisively act in ambiguous and/or urgent circumstances
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