As a Senior Manager Submissions Strategy, 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. You will lead complex projects division-wide, leveraging your expertise to develop strategic plans, resolve challenges, and drive teams towards achieving objectives. •Provide strategic direction to teams on regulatory logistics and serve as a regulatory operational liaison on the project team throughout the product lifecycle •Drive global submission management activities for assigned assets and provide guidance for related activities. •Partner with product teams and/or third-party partners to manage required regulatory activities. •Promote the use of Document Management and Archival systems and standard document authoring. •Drive communication and propose refinements for the emerging markets through collaboration with stakeholders. •Lead the interpretation of regulatory guidelines and requirements to produce business processes and ensure implementation. •Partner with key stakeholders to ensure quality and consistency of processes and maintain compliance with regulatory obligations. •Serve as a source of innovative ideas, seeking and developing efficiencies within the Submissions process. •Drive and implement strategies for operational excellence through interaction with global regulatory leaders and product teams.
Work Location Assignment: Hybrid Purpose Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. Disability Inclusion Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here! Regulatory Affairs