Product License Manager, Associate
Share
Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
Were 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)
Masters 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 AffairsRequired Experience:
Manager
Key Skills
- Marketing
- Quality Assurance
- Agile
- Product Demos
- Analysis Skills
- Jira
- Project Management
- Product Management
- Qualitative Analysis
- Confluence
- Internet Of Things
- Product Development
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
