GMO GTx (Regulatory) Submission Manager
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GMO GTx Submission Manager
Provides an interface to Regulatory and GPD partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory Environmental Risk Assessment (ERA) submissions associated with Regulatory Clinical trial Application to selected Health Authorities.
The GMO GTx Submission Manager is accountable for working with relevant business lines and the Global CTA SM to develop an operational strategy for Submission of the Environmental Risk Assessment (ERA) in trials that will be conducted with investigational medicinal products that contain or consist of genetically modified organisms ("GMOs")
They may operate as regulatory operational Subject Matter Expert for a GMO GTx CTAs and drive submission teams towards the timely delivery of globally compliant submission-ready components that contribute the ERAs timely delivery.
The GMO GTx Submission Manager may be assigned as a Global CTA Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for other selected TAs and Geographies .
Drives global submission management activities for their assigned Therapy Area. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA and ERA submission development and execution for designated protocols and/or geographies.
Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
Prepare, review and submits submissions to HA, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct for Gene Therapy portfolio.
Manages the compilation for ERA, contributing to the authoring of documentation as required
Acts as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on GMO GTx regulations and requirements.
Leads the implementation of global SOPs and WI to meet evolving business needs.
Escalates, informs, and resolves any issues that may impact the delivery to regional and local partners or Health Authorities.
Serves as a major source of innovative ideas seeking and developing efficiencies and effectiveness within the Submissions process by collaboration with key customer and supplier groups and business partners,
Promotes professional development through mentoring and motivating and education of colleagues
Technical Skill Requirements and Qualifications
Significant knowledge of the drug development process, Regulatory Affairs and submissions management.
Expert in regional and national regulator filing guidelines and ERA requirements.
Demonstrated ability to lead and deliver through others in a matrix model
Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances
Robust organizational management skills
Advanced knowledge of the processes, systems and regulatory guidance and a detailed understanding/knowledge of principles and concepts of other disciplines
Proven ability to embrace new technologies and processes and drive their implementation
B.S./B.Sc is in Pharmacy, Life Sciences, or Business equivalent relevant professional experience will be considered.
In-depth understanding and proven execution of CTA and ERA processes globally
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
Advanced Knowledge and understanding of Directive 2009/41/EC and Directive 2001/18/EC
Understanding of EU Clinical Trial Regulation Desirable
Familiarity with pharmaceutical organizational structures, systems, and culture is preferred
All applicants must have the relevant authorisation to live and work in the EU / UK (host country as applicable).
The closing deadline for applications is October 31st.