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.

Job Responsibilities

• 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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