Director, Global Regulatory Affairs - Vaccines

ROLE SUMMARY

• 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

ROLE RESPONSIBILITIES

• 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

BASIC QUALIFICATIONS

• 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

PREFERRED QUALIFICATIONS

• MS, PharmD, or PhD is preferred
• Additional global Health Authority regulations knowledge is preferred
• Vaccines regulatory experience is preferred

PHYSICAL/MENTAL REQUIREMENTS

None

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional Travel may be required

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These 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 disclosure. Subject 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 Act. Therefore, 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 government. If 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 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.

Regulatory Affairs

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