Regulatory Submission Operations Associate

hace 2 semanas

Suba, Colombia 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

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
- Provide operational support to Hub Submission team within Submissions Management organization to prepare and deliver regulatory dossiers to regional or national countries for submission to the regulatory agencies.

**Qualifications**:
Must-Have
- Bachelor's Degree
- Demonstrated experience
- Relevant experience in Pharmaceutical Industry
- Demonstrated coordination of activities in a highly regulated environment
- Demonstrated experience working in a challenging customer service environment
- Demonstration of attention to detail
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
- Good knowledge of English, spoken and written

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

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