Product License Manager, Associate

Use Your Power for Purpose

We're committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your role will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations. Your contributions will help us bring life-saving medicines and vaccines to patients around the world more efficiently and effectively.

What You Will Achieve

In this role, you will:

• Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.

• Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations,

• Delivery of Product License Maintenance Portfolio in a timely and quality manner.

• Implementation of solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes

• Participation on global/local teams to complete assignments and tasks within a specific task force/project. Contributes to the completion of moderately complex projects.

• Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these.

• Utilization support of electronic technologies for submissions and tracking of documentation

• Utilizes regulatory expertise, experience and technical skills to deliver on moderately complex tasks to support submissions to the Regulatory Authorities

• Has a strong understanding of the relevant regulatory industry and local business environment.

Here Is What You Need (Minimum Requirements)

• 2+ years of experience

• Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers

• Knowledge of drug development process

• Familiarity with systems and electronic technologies that support submission and planning activities

• Exceptional organizational skills and a keen attention to detail

• Ability to present scientific data effectively, both verbally and in writing

• Proficiency in English

Bonus Points If You Have (Preferred Requirements)

• Master's degree

• Familiarity with pharmaceutical organizational structures, systems, and culture

• Experience in project management

• Strong analytical and problem-solving skills

• Ability to work independently and as part of a team

• Ability to manage multiple projects and priorities simultaneously

• Experience with global regulatory submissions and requirements

  
Work Location Assignment: Hybrid

EEO (Equal Employment Opportunity) & 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, or disability.

Regulatory Affairs