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Sr Cta Submission Manager
il y a 3 semaines
Why Patients Need You
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.
What You Will Achieve
You will be responsible for directing the development, quality control and publication of submissions relating to asset development and registration, driving adherence to external regulatory guidelines and compliance timelines for multiple submission types. Providing strategic direction to teams on regulatory logistics, you will serve as a regulatory operational liaison on the project team throughout the product lifecycle. You will coordinate timely provision of product information through submissions that conform to external and internal requirements, authoring and redacting content as applicable based on external regulations and submitting product information to regulatory authorities.
As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It- Develop ideas and lead projects across the division and develop plans to achieve objectives.- Drive global submission management activities for assigned assets and provide guidance for related activities.- Partner with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables.- Promote 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.- Drive communication and propose refinements for the emerging markets through collaboration with stakeholders and regulatory leaders.- Lead the interpretation of regulatory guidelines and requirements to produce business processes and ensure that their implementation where appropriate at global and local level.- Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies and timelines.- Partner with key stakeholders and ensure quality and consistency of processes and ensure that Pfizer delivers on key regulatory submission milestones and maintains compliance with applicable regulatory obligations.- Serve as a 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.- Drive and implement strategies that achieve operational excellence through interaction with global regulatory leaders and associated product teams.- Represent Pfizer with Health Authority and in industry discussions/ initiatives and contribute to changes in policies and strategies to meet evolving business needs.
Qualifications
Must-Have- Bachelor's Degree (BA/BS) and9+ years of experience.- Significant knowledge of the drug development process, Regulatory Affairs and submissions management.- Strong verbal and written communication skills.- Advanced Microsoft Office Suite skills and strong competency with tools.- Note: Tools to be added by Hiring Manager.
Nice-to-Have- Master's degree(MA/MBA/MS) and 7+ years of experience.- Doctorate (PhD/PharmD/JD) and 4+ years of experience.- Experience in performing complex data analysis.- Strong understanding of statistical modeling and data analytic methodologies.- Sound knowledge of product lines, processes and associated technologies.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
LI-PFE
