Role Summary

Provides an interface to Regulatory and GPD partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory CTA submissions to regional partners and selected Health Authorities. The CTA Submission Manager (CTA-SM) is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components. The CTA-SM may be assigned as a Hub Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected geography.

Profile

QUALIFICATIONS

BASIC QUALIFICATIONS

• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
• In-depth understanding and proven execution of CTA processes globally
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
• Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
• Understanding of EU Clinical Trial Regulation Desirable
• Familiarity with pharmaceutical organizational structures, systems, and culture is preferred

SKILLS

• Proven aptitude in leadership, problem solving and logistics
• Ability to work on multiple highly complex projects simultaneously.
• Demonstrated attention to detail.
• Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.
• In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
• Ability to operate seamlessly

Offer

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

To apply please visit our website www.pfizercareers.com and search job id 4879379 for Clinical Trial Applications (CTA) Submission Manager