My Pfizer Experience: Estudiante en Practica - Químicos Farmacéuticos o Ingenieros Biomédicos

Beschreibung:

The Regulatory Operations Apprentice supports the operational management of regional and/or national regulatory activities enabling compliant regulatory execution and submission delivery for markets governed by designated Health Authorities (HAs). Based within Global Regulatory & International Operations (GRS RIO), this role sits within a team operating in a highly regulated environment and working to tight, business-critical deadlines. The primary focus is on assigned region/countries, with additional responsibility to support other locations through utilization of global tools and systems.

Collaborating closely with experienced team members, the apprentice will contribute to operational execution as well as special projects such as process improvements, system or tool enhancements, data quality initiatives, and operational efficiency efforts. The role executes designated regulatory operational tasks through the application of defined standards and tools. Through hands-on execution, the role applies regulatory standards, Health Authority expectations, and operational excellence practices while building technical fluency through work with regulatory systems, structured data, analytics, and emerging digital or AI-enabled tools. Activities may include support to regulatory operations processes such as information and document management, coordination of submission-related activities, system-based task execution, and operational support to ensure compliant regulatory outcomes.

Given the global scope of the organization, a key requirement of this role is the ability to effectively collaborate across multiple cultures and functions.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

* Provide operational support to assigned Regulatory Operations sub-teams, contributing to execution of regulatory activities across the product lifecycle.

* Deliver assigned activities with quality and timeliness, in accordance with applicable policies, SOPs, work instructions, guidelines, or service level agreements.

* Adhere to the approved working practices and QC/QA requirements, ensuring appropriate use of regulatory systems and tools and preserving internal and regulatory compliance.

* Support dossier management activities, including tracking document readiness/receipt, coordinating inputs, and maintaining submission plans under guidance.

* Support operational activities related to dispatch & submissions, including coordination and tracking to meet submission milestones and Health Authority timelines.

* Support regulatory operational activities across the product lifecycle, including coordination, tracking, and system-based execution to support timely and compliant regulatory outcomes.

* Support data entry, quality checks, and reporting within regulatory information systems and related tools to ensure data integrity and accurate tracking of regulatory activities

* Contribute to metrics, dashboards, and reporting deliverables, helping translate operational and regulatory data into clear summaries for different stakeholder audiences (data storytelling).

* Participate in process documentation, compliance tracking, and continuous improvement initiatives that strengthen submission quality and inspection readiness.

* Support data quality and governance initiatives and explore responsible use of digital or AI-enabled tools to improve efficiency and quality in day-to-day operations.

* Complete required on-the-job training and curriculum activities to maintain compliance and build capability in Regulatory Operations best practices.

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

* Currently in the final year of university, pursuing a Bachelor's degree in a Life Sciences or related discipline, desirable Chemistry or Biomedicine.

* Proficient in English (B2-C1), reading, written and spoken.

* Strong knowledge of MS Office applications including Word, Excel, PowerPoint and SharePoint.

* Excellent communication and interpersonal skills.

* Strong attention to detail and ability to follow structured processes in a regulated environment

* Ability to learn quickly, adapt to change, and work effectively with individuals from diverse backgrounds and experiences

* Analytical and problem-solving skills, with ability to interpret operational data and identify improvement opportunities.

* Clear written and oral communication skills; able to summarize complex information and present insights to different audiences. Demonstrated ability to learn quickly.

* Team-oriented mindset with strong collaboration skills; able to work autonomously under guidance and manage multiple priorities.

* Desirable knowledge or demonstrated interest in the responsible use of Artificial Intelligence (AI), including exposure to the development, configuration, or application of AI agents to support operational efficiency and decision-making.

Work Location Assignment: Hybrid

"En Pfizer tenemos el objetivo de ser tan diversos como los pacientes y las comunidades a las que servimos, a través de una cultura vibrante y enriquecida por la mezcla de nacionalidades, identidades, edades, géneros, experiencias, tradiciones y capacidades. Estamos comprometidos con atraer talento basándonos en las habilidades y experiencias imprescindibles para realizar el trabajo.
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EEO (Equal Employment Opportunity) & Employment Eligibility

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