Provides comprehensive program management and execution of regulatory strategic and operational deliverables
Responsible for ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality
Develop regulatory goals in partnership with the Global Regulatory Lead
Monitors activities across all regulatory team members for operational efficiency ensuring the program delivers on time and within scope
Directs the regulatory team in the preparation, implementation, maintenance, communication, and management of integrated risk management plans
Ensures effective, accurate, and timely communication of regulatory information to meet the needs of the product team and stakeholders

Requirements

Bachelor’s Degree with 6+ years of experience or Master’s Degree with 5+ years of experience
Command of program management skills and considerable expertise in drug development (Oncology preferred)
Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable
Experience with the planning and execution of major regulatory submissions (e.g. NDA/BLA/MAA) is preferred
Track record of performance, delivery and team effectiveness in a complex matrix team environment
Proven ability to drive results
Knowledge and experience in drug development, medical, and/or commercial disciplines
Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills
Knowledge of and experience with clinical operations/clinical trial execution is desirable
Experience with Microsoft Project, Planisware, and/or OnePager is preferred

Benefits

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental and vision coverage

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

program managementregulatory submissionsdrug developmentrisk managementclinical operationsclinical trial execution

Soft Skills

leadershipnegotiationinterpersonal communicationmeeting facilitationteam effectivenessdriving results

Certifications

Project Management Professional (PMP)