|Hours||37.5 - 37.5 Hours|
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
Reports to Head, CTA Liaison within GPD, Global Regulatory Operations, Submissions Management
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 CTA submissions to regional partners and selected Health Authorities.
The CTA Submission Manager (CTA-SM) is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.
The CTA-SM may be assigned as a Hub Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected geography.
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 and execution for designated assets 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.
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
Acts as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, e.g., Competent Authority submission requirements
Coordinates submission production and assists with definition, development, and implementation of global submissions policies and technologies to meet evolving business needs. · Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission 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 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 demeanour
Operates as single BU Liaison point of contact for Regional Regulatory Leads and designated CTAs.
Leads the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at global and local level.
Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department
Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently
Considered a technical resource within the group
Technical Skills Requirements
Proven aptitude in leadership, problem solving and logistics
Ability to work on multiple highly complex projects simultaneously.
Demonstrated attention to detail.
Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.
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 organizations.
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
Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
Understanding of EU Clinical Trial Regulation Desirable
Familiarity with pharmaceutical organizational structures, systems, and culture is preferred