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.
Regulatory Affairs