Director, Global Regulatory Sciences - Vaccines

Use Your Power for Purpose
At Pfizer, we are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer vaccines. By maintaining high standards and adapting to regulatory changes, you will play a key role in ensuring that our life-saving treatments reach those in need promptly and safely.
What You Will Achieve
ROLE SUMMARY
This Director, Global Regulatory Sciences - Vaccines position is the Global Regulatory Lead and US Regional Regulatory Lead for the combination Influenza/COVID mRNA vaccine program and the US Regional Regulatory Lead for the COVID-19 mRNA vaccine program. This role is responsible for developing and executing global (Influenza/COVID-19) and US (COVID-19) regulatory strategies and ensuring compliance with applicable regulations. This role involves leading/participating in Regulatory and Cross-functional teams, managing submissions, and interacting with Regulatory agencies worldwide (Influenza/COVID-19) or the US FDA (COVID-19). At Pfizer Global Regulatory Sciences contribution is "end to end". The responsibilities of this position will include development, licensure and post-authorization involvement.
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, 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 a 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.

Here Is What You Need (Minimum Requirements)

• BS is required. MS, PharmD, or PhD preferred
• Prior clinical regulatory affairs experience in vaccines is required, at least 8 years.
• Deep understanding of drug development and license maintenance processes
• Proficiency in regulatory codes, guidance, and technologies
• Experience with systems and electronic technologies that support regulatory activities
• Proficiency in Microsoft Office
• Excellent communication skills

Bonus Points If You Have (Preferred Requirements)

• Comfortable with ambiguity and adept at facilitating discussions to uncover the best possible solutions
• Strong and collaborative service provider and business partner orientation
• Ability to effectively work with or lead a team within a matrix structure
• Experience in fostering a culture of innovation and continuous improvement
• Strong leadership and team management skills
• Strategic thinking and problem-solving skills
• Ability to adapt to regulatory changes and maintain high standards

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.
PHYSICAL/MENTAL REQUIREMENTS
N/A
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Limited Travel
Work Location Assignment: Hybrid/site-based average of 2.5 days per week requirement.
The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Regulatory Affairs