Hub Dossier Associate I

Use Your Power for Purpose

We're 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's medicines and vaccines. Your role will be essential in ensuring that our regulatory submissions are prepared, published, tracked, and quality-controlled to meet the highest standards, ultimately supporting patients globally.

What You Will Achieve

In this role, you will:

• Assist in the preparation, publication, tracking, and quality control of regulatory submissions, ensuring compliance with document management standards.

• Contribute to project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.

• Make decisions within limited options to resolve basic problems under the supervisor's direction, working in a structured environment using established procedures.

• Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor.

• Execute designated operational tasks using standards and tools, conforming to regulatory submission milestones and obligations.

• Help interpret regulatory guidelines to produce business requirements and ensure their implementation at the local level, promoting quality as a best practice.

• Support regulatory activities associated with new food supplements in development and 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.

• Communicate with internal team members about execution and strategy as needed, actively pursuing training in technical and personal skills relevant to the role.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with any years of experience, or an Associate's degree with 2 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience

• Demonstrated experience in electronic submissions build within the Pharmaceutical Industry

• Proven coordination of activities in a highly regulated environment

• Experience working in a challenging customer service setting

• Knowledge of the drug development process

• In-depth understanding of systems and electronic technologies used to support submission and planning activities

• Good knowledge of English, both spoken and written

Bonus Points If You Have (Preferred Requirements)

• Proficiency in managing timelines, resources, and stakeholder communications

• Proven track record of successfully leading projects from inception to completion

• Strong organizational skills and the ability to multitask in a fast-paced environment

• Experience in risk management and problem-solving to navigate project challenges

• Strong attention to detail and analytical skills

• Experience using common AI tools, including generative technologies such 
as ChatGPT or Microsoft Copilot, to support problem solving and enhance 

  
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