Hub Submission Associate
Job posting number: #7151781 (Ref:pf-4886375)
Posted: June 1, 2023
Application Deadline: Open Until Filled
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will Achieve
You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contribute to the completion of project milestones and organize own work to meet project task deadlines.
- Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
- Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
- Promote quality as a best practice based on knowledge of regulatory requirements, departmental guidelines, and Quality Control (QC) experience.
- Support the regulatory activities associated with allocated new food supplements in development.
- Compile, verify accuracy, and sort regulatory license information for products identified for withdrawal.
- Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.
- Communicate with internal team members about execution and strategy as needed
- Actively pursue training in technical and personal skills relevant to the Certificate Signing Request Coordinator role.
- Act as a subject matter expert on global regulatory requirements in the cross functional team.
- Bachelor's Degree
- Demonstrated experience
- Relevant experience in electronic submissions build within the Pharmaceutical Industry
- Demonstrated coordination of activities in a highly regulated environment
- Demonstrated experience working in a challenging customer service environment
- Knowledge of the drug development process
- In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation
- Good knowledge of English, spoken and written
- Experience in project management
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs
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.