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