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JOB SUMMARY
The CTRSE Regional Submission Manager, is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics, leading project management activities for Clinical Trials, across multiple TAs, Phases and Markets. The CT RSM Provides an interface to GSSO partners, offering project leadership and expertise in the strategic and operational execution of regulatory Clinical Trial Application (CTA) submissions to regional partners and selected Health Authorities/Central Ethics Committees. This role will focus on the CTA submissions in China and other APAC countries.
The Clinical Trial Submission Manager (CT-SM) is accountable for working with contributing business lines to lead submissions execution timelines for designated CTAs. They may operate as regulatory Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components. The CT-SM is required to author & deliver customized documentation for selected submissions across multiple markets.
The CT-SM may be assigned as a Global Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected geography.
JOB RESPONSIBILITIES
● Drives Regional submission management activities for their assigned protocols. Partners with global Submission and Portfolio Manager, GSSO lines and/or third-party partners, with responsibility for representation and management of required regulatory and Central Ethics activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.
● Support and leads Regional and global efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
● Liaises with GSSO, regarding essential documents that cross both HA and EC submission and translation processes driving compliance and timely delivery,
● Prepare, review and submit submissions to HA/Regional CTA, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
● Manages the compilation for submission build, contributing to CTA & CE approvals and authoring documentation as required. Responsible for the co-ordination of translations for local documents required for submission.
● Acts as Subject Matter Expert for CTRSE 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.
● Promotes professional development through mentoring and motivating colleagues.
● Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently.
● Drives communication and proposes refinements through collaboration with stakeholders and regulatory leaders. Serves as Pfizer CTRSE representative with Health Authority meetings, Industry discussions/ initiatives.
● Contributes to changes in policies and strategies to meet evolving business needs.
● Self-initiates assignments, developing innovative ideas to resolve complex problems and leading the execution of projects.
QUALIFICATIONS / SKILLS
SKILLS
● Significant knowledge of the drug development process, Regulatory Sciences and submission management and publishing.
● Demonstrated understanding of regional and national regulator filing guidelines and dossier requirements.
● Demonstrated ability to lead and deliver through others in a matrix model.
● Demonstrated ability to deliver swift decisions 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.
QUALIFICIATIONS
● A degree in Pharmacy, Life Sciences, Business or Information Technology; Minimun 6 years’ experience in clinical trials; equivalent relevant professional experience will be considered.
● Comprehensive understanding of ICH/GCP guidelines, as well as CTA regulations and process in China and other APAC countries.
● 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.
● Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
● Fluent in both written and spoken English.
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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs