Regulatory CTA Submission Manager
Proclinical are in partnership with a large biotech in search for a Regulatory CTA Submission Manager to provide an interface to regulatory and GPD partners, offering project leadership and expertise in the logistics involved with execution of regulatory CTA submissions to partners.
- Drives global submission management activities for their assigned assets. 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 submission development
- Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines and understand project strategy.
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines.
- Liaises with Study Management, regarding essential core documents that cross both HA and EC submission and translation processes
- Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- Responsible for the co-ordination of translations for core documents required for submission
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required
- Promotes professional development through mentoring and motivating colleagues.
- Drives connectivity and implements refinements in the Emerging Markets partner model through collaboration with peers
- Promotes the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
- Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor
- Operates as single BU Liaison point of contact for Regional Regulatory Leads and designated CTAs.
- Considered a technical resource within the group
- Drives communication and proposes refinements in the Emerging Markets partner model through collaboration with stakeholders and regulatory leaders
Skills and Requirements
- B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
- In-depth understanding and proven execution of CTA processes globally
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
- In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
- Ability to operate seamlessly and influence direct and indirect reports, as well as across organisations.
- Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances
- Robust organisational 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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.