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Use Your Power for Purpose
At Pfizer, we're dedicated to bringing medicines to the world faster without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your commitment and expertise are vital in expanding and accelerating patient access to Pfizer's medicines and vaccines.
What You Will Achieve
In this role, you will:
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Develop and lead innovative projects across the division, creating comprehensive plans to meet objectives and manage complex projects
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Formulate and implement regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations, and lifecycle management
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Provide strategic contributions to country or cluster markets, supporting leadership teams and fostering strong partnerships
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Understand, monitor, and assess the impact of local regulations and trends in the regulatory environment on key stakeholders
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Ensure compliance with local regulations by maintaining licenses, implementing corporate regulatory processes, SOPs, and systems, and ensuring team training
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Update the Local Product Document (labeling) in line with relevant regulations and SOPs
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Implement systems, processes, and procedures to enhance regulatory strategy productivity and facilitate information sharing across relevant lines
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Deliver project/product strategies, including label and risk assessments for assigned projects/products, ensuring business compliance and adherence to regulatory standards
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Develop and strengthen relationships with key external agencies to support the development and implementation of registration strategies
Here Is What You Need (Minimum Requirements)
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A BA/BS with at least 6 years of experience or MBA/MS with at least 5 years of experience or PhD/JD with at least 1 year of experience or MD/DVM with any years of experience
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Deep understanding of both Regional and Global regulatory environments
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Comprehensive knowledge of drug development practices, rules, regulations, and guidelines
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Solid grasp of the business and financial environment
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Strong project management skills
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Ability to manage multiple projects simultaneously
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Excellent communication and negotiation skills
Bonus Points If You Have (Preferred Requirements)
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Master's degree with 7+ years of experience or a Doctorate (PhD/PharmD/JD) with 4+ years of experience
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Strategic thinking and problem-solving skills
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Experience in leading cross-functional teams
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Proficiency in regulatory submission and approval processes
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High level of attention to detail and organizational skills
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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