Regulatory Affairs Specialist
hace 3 semanas
We're at the forefront of innovation, driven by a relentless pursuit of breakthroughs that transform patients' lives. Our mission is to bring life-changing medicines to the world.
About Pfizer, S.A. De C.V.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.
Job Responsibilities:- Planning and Execution: Participate in planning regulatory strategies for product submissions and lifecycles, including APIs related to products under responsibility.
- Submission Coordination: Coordinate and execute activities related to dossier planning and submission (paper and/or electronic) for initial registration and maintenance of drug products, including product renewals for assigned portfolios.
- Clinical Trials Applications: Manage Clinical Trial Applications for country acceptability in terms of content, according to local regulations and requirements.
- HA Query Management: Oversee HA query management activities.
- Education: Pharmacist graduate or life science degree.
- Experience: Minimum 3 years of experience as Regulatory Analyst (Human Medicinal Products).
- Demonstrable Experience: Proven ability to consistently deliver on time and quality standards, manage complex regulatory issues, and work under pressure.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. The estimated salary for this position is $90,000 per annum, depending on location.
Working Location and Assignment:This role will be based in a hybrid environment, allowing for flexible working arrangements. We are an Equal Employment Opportunity employer and welcome applications from qualified candidates regardless of their background or circumstances.
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