Regulatory Analyst

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

As an associate, your focus on the job will contribute in achieving your team’s tasks and goals. This is a multifaceted role that will offer you a number of opportunities to enhance your skills. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
- Develop detailed understanding of labeling and artwork regulatory guidelines and technical requirements for assigned the countries.
- Responsible for the execution of labeling and artwork processes in cooperation with stakeholders (eg. Product Strategist, Commercial, Operations) and other teams as applicable.
- Prepare and/or coordinate dossier preparation guaranteeing quality dossiers, fulfilling country regulations and Pfizer standards.
- Guarantee timely regulatory authority submission of the dossiers according to Pfizer policies and regulatory strategy.
- Ensures systems and databases are timely updated per corporate policies.
- Manage the process to answer regulatory authority queries in coordination with stakeholders to guarantee approval of updated labeling and/or artwork information reflecting global Pfizer position for products as best in class.
- Coordinate with internal stakeholder the development and approval of the artworks.
- Ensure stakeholders are notified about last labeling approved by regulatory authority, as applicable.
- Provide strategic support to the in-country regulatory strategists to facilitate achievement of labeling objectives.
- Active participation and/or timely support in meetings, quality investigations and audit interviews impacting labeling and/or artwork operation, when required.

**Qualifications**:
Must-Have
- Bachelor's Degree
- Demonstrated experience
- Proven ability to consistently deliver to time, cost and quality standards
- Operational knowledge of hardware and software tools required for the job
- Excellent organizational skills and attention to detail
- Knowledge of documentation practices
- Fluent in English, verbal and written

Nice-to-Have
- Project Management experience
- Knowledge across multiple therapeutic areas

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

LI-PFE