Pfizer Director, Global Regulatory Affairs in Providence, Rhode Island
Provide strategic regulatory expertise as regulatory representative to Product Team(s) within the mRNA Vaccine Franchise
Within the Global Regulatory Strategy Team (GRST), develop, align, manage and implement the regulatory strategy
Be accountable for delivering the project goals and aligning the regulatory strategy with global and business regional needs
Be accountable for timely submissions and approvals with commercially attractive labelling across the regions
Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s)
Project(s) assigned can be in development and/or at post-authorization stage
Responsible for the production, updating and communication of global regulatory strategies for assigned projects/ products, mechanisms of action and/or indications
Provides regulatory expertise and leadership for the project/product.
Member of appropriate Project(s)/Product(s) teams
In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy
Ensures appropriate representation for Pfizer for the project/product with Health Authorities
Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues
Ensures that all regulatory development process commitments are clearly communicated, monitored and met
Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy
Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives
Develops strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders
Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRPL and other stakeholders as required
Participates in appropriate governance committees, as necessary
BS (Bachelors) is required
10+ years of experience is required
Prior clinical regulatory affairs experience is required
Advanced knowledge of US FDA regulations is required
Experience interacting directly with US FDA is required
MS, PharmD, or PhD is preferred
Additional global Health Authority regulations knowledge is preferred
Vaccines regulatory experience is preferred
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional Travel may be required
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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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 status. Pfizer 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 IRCA. Pfizer is an E-Verify employer.
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