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:

Develop and lead innovative projects across the division, creating comprehensive plans to meet objectives and manage complex projects

Formulate and implement regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations, and lifecycle management

Provide strategic contributions to country or cluster markets, supporting leadership teams and fostering strong partnerships

Understand, monitor, and assess the impact of local regulations and trends in the regulatory environment on key stakeholders

Ensure compliance with local regulations by maintaining licenses, implementing corporate regulatory processes, SOPs, and systems, and ensuring team training

Update the Local Product Document (labeling) in line with relevant regulations and SOPs

Implement systems, processes, and procedures to enhance regulatory strategy productivity and facilitate information sharing across relevant lines

Deliver project/product strategies, including label and risk assessments for assigned projects/products, ensuring business compliance and adherence to regulatory standards

Develop and strengthen relationships with key external agencies to support the development and implementation of registration strategies

Here Is What You Need (Minimum Requirements)

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

Deep understanding of both Regional and Global regulatory environments

Comprehensive knowledge of drug development practices, rules, regulations, and guidelines

Solid grasp of the business and financial environment

Strong project management skills

Ability to manage multiple projects simultaneously

Excellent communication and negotiation skills

Bonus Points If You Have (Preferred Requirements)

Master's degree with 7+ years of experience or a Doctorate (PhD/PharmD/JD) with 4+ years of experience

Strategic thinking and problem-solving skills

Experience in leading cross-functional teams

Proficiency in regulatory submission and approval processes

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.