Job Description

Use Your Power for Purpose

At Pfizer, we are committed to bringing medicines to the world at a faster pace 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 dedication 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:

• Assist in the preparation, publication, tracking, and quality control of regulatory submissions, ensuring compliance with document management standards

• Coordinate activities related to enterprise-wide regulatory management systems and provide guidance on moderately complex projects

• Apply skills and discipline knowledge to contribute to departmental work, making decisions to resolve moderately complex problems and developing new options

• Work independently on assignments, seeking directional review for unusual or complex problems, and review the work of colleagues in a mentor role

• Guide operational teams in managing projects, preparing resource forecasts, and identifying areas for improvement in products, processes, or services

• Act as a point person for regulatory agency interactions, including preparation of briefing packages and strategy for meetings, inspections, and responses to agency letters

• Understand and challenge scientific arguments, identify regulatory scientific data needs, and solve regulatory issues to influence the development of new global products and improvements to existing products

• Manage registrations of existing customer products in compliance with applicable regulations and support global team efforts to ensure high-quality, compliant submissions

• Provide daily regulatory support to Global Product Development teams and lead the logistics involved with regulatory Clinical Trial Application (CTA) submissions

• Manage the preparation of registration packages, responses to deficiency letters, and suggest system improvements to reduce cycle time and increase efficiency

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience

• Demonstrated experience in regulatory affairs, research and development, or quality assurance/compliance

• Experience working directly with regulatory agencies

• Strong knowledge of the drug development process, regulatory affairs, CTA, and submissions management

• Sound knowledge of applicable portions of agency guidance documents and regulations

• Ability to exercise good judgment within company policy and health authority regulations with good negotiation skills.

• Excellent written and interpersonal communication skills

Bonus Points If You Have (Preferred Requirements)

• Master's degree with relevant pharmaceutical experience, particularly in the lifecycle management of approved applications.

• Proven ability to manage multiple projects and deadlines

• Proficiency in regulatory submission software and tools

• Excellent organizational and time management skills

• Strong attention to detail and accuracy

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Job Requirements