Regulatory Science Analyst

hace 2 semanas

Ciudad de México Pfizer A tiempo completo

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

Interact with key stakeholders and perform activities related with the product lifecycle maintenance. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.

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 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
- Contribute to the completion of project milestones and organize own work to meet project task deadlines.
- Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
- Responsible for the preparation, support and finalization of Global Regulatory Strategy Documents (GRSD), variations for Lifecycle Management (LCM) submissions and ensure effective data presentation and quality, by self or under guidance
- Support continuous improvement of selected processes relating to Human health submissions and selected drug and non-drug specific projects and related activities.
- Maintain the required regulatory databases to ensure compliance.

**Qualifications**:
Must-Have
- Bachelor's Degree
- Experience: about 1 year as Regulatory Affairs Analyst
- Good skills on communication, collaboration, negotiation and problem solving
- English, written and spoken
- Computer literacy and ability to learn new systems

Nice-to-Have
- Knowledge of regulatory processes and documents, knowledge of therapeutic areas
- Change Agile
- Team player

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.

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