Hybrid Senior Manager, Global Regulatory Diagnostics Strategy – Oncology

at Pfizer

• Job title: Senior Manager, Global Regulatory Diagnostics Strategy – Oncology
• Job type: Full Time
• Experience level: Senior
• Salary: $135,100 - $225,100 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Senior Manager for regulatory diagnostics strategy at Pfizer, representing regulatory affairs and enhancing patient access to medicines. Involves guiding compliance and efficiency in complex regulatory frameworks.

Responsibilities

• Represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks
• Provide regulatory strategic direction to teams overseeing clinical development of products and diagnostics
• Interact with regulatory agencies and diagnostics partners, including negotiations to expedite regulatory approval of trials co-developing medicinal and diagnostic products
• Support submission of medicinal and diagnostic product registration, progress reports, supplements, amendments, and periodic reports
• Evaluate existing internal processes and procedures related to implementation of diagnostic regulations and support other functions to identify gaps
• Provide guidance to operational teams for managing projects with diagnostics components
• Develop and maintain tools to ensure tracking of projects, deliverables, and accomplishments
• Work in collaboration with stakeholders across the organization to deliver efficiencies in regulatory submissions and processes

Requirements

• Bachelor's Degree (higher degree preferred)
• 5+ years of relevant experience
• Demonstrable experience of effective delivery in a complex matrix environment
• Regulatory experience to include knowledge of EU IVDR/CTR submission processes and IVDR requirements
• Regulatory experience including knowledge of New Drug Application (NDA)/Investigational New Drug (IND) submission processes
• Regulatory experience including knowledge on US device submissions (IDE, 510(k), de Novo, PMA) and CAP/CLIA laboratory requirements
• In depth knowledge of national/regional regulatory legislation and guidelines
• Knowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicine
• Leadership qualities and management skills, team oriented with problem solving skills
• Strong written and verbal communication and interpersonal skills

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