Job type full-time
Full job description
Why patients need you
We`re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrityAdhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detailYour 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 typesProviding strategic direction to teams on regulatory logistics, you will serve as a regulatory operational liaison on the project team throughout the product lifecycleYou 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 divisionYour ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges, and recommending best practices for improvementsWhile 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 .
Bachelor`s degree (ba/bs) and 9+ 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
(tools to be added by hiring manager ) .
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 .
Other job details:
Last date to apply for job:
Additional location information: united states - pennsylvania - collegeville; united states - connecticut - groton; united states - remote; united states - new york - manhattan; united states - new jersey - peapack
No relocation package
Eligible for employee referral bonus
Pfizer requires all u.sNew hires to be fully vaccinated for covid-19 prior to the first date of employmentAs required by applicable law, pfizer will consider requests for reasonable accommodations.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulationsThese laws and regulations require pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosureSubject to further legal review and statutory or regulatory clarification, which pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the sunshine actTherefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the governmentIf you have questions regarding this matter, please do not hesitate to contact your talent acquisition representative.
Eeo & employment eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran statusPfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the immigration and nationality act and ircaPfizer is an e-verify employer.