Regulatory Affairs 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 the country(ies).
- Responsible for the execution of labeling and artwork processes in cooperation with in-country Regulatory, Medical, Hub Labeling Manager (HLM), Artwork and Labeling Implementation Management (ALIM) and Marketing teams 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 labeling category and/or regulatory strategy.
- Ensure submission and approval timelines, and country registration requirements/guidelines are accurately captured and current in Global Pfizer Systems.
- 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 ALIM the development and approval of the artworks.
- 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.
- Liaise and present information to all stakeholders using the most effective means of communication.
- Contribute to the development of continuous improvement of business practices associated with processes and tools.

**Qualifications**:
Key Competencies
- Successful experiences of teamwork, seeking and proposing alternative solutions, achieving goals in an inclusive manner
- Project management skills
- Quality Focus and detailed oriented
- Customer orientation
- Analysis and problem solving
- Effective communication
- Strategically minded
- Outward looking
- Country/regional knowledge
- Negotiation skills
- Network and alliance building/ peer relationships
- Influencing
- Change agile

**Qualifications**:

- Bachelor’s degree in Pharmacy.
- Previous experience in regulatory is an advantage.
- Knowledge of the current framework for labeling and artwork is an advantage.
- English language advanced level: reading, writing, speaking and listening skills that are easily manifested in known contexts regarding work. Fluency in Spanish and in Portuguese may be an advantage.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

LI-PFE