Senior Manager, Global Regulatory Diagnostics Strategy for Oncology

Pfizer • Bothell, WA

79d • $135,100 - $225,100

About The Position

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines. You will represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks. You will play the critical role of providing regulatory strategic direction to teams overseeing clinical development of products and diagnostics. This will involve interacting with regulatory agencies and diagnostics partners, including negotiations to expedite regulatory approval of trials co-developing medicinal and diagnostic products. Through your expertise, you will be the diagnostic regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing, commercialization, research project teams and government regulatory agencies. Your understanding of regulatory procedures will help support the submission of medicinal and diagnostic product registration, progress reports, supplements, amendments, and periodic reports. These skills will help you evaluate existing internal processes and procedures related to implementation of diagnostic regulations and support other functions to identify gaps and effect change, including modifying or creating processes, to maintain business critical compliance. As a Senior Manager, you provide guidance to operational teams for managing projects with diagnostics components. Your planning skills will help prepare forecasts for resource requirements and improve products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. It is your dedication that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

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

Nice To Haves

• Master's degree/PhD/PharmD
• Relevant pharmaceutical experience

Responsibilities

• Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the division.
• Develop and maintain tools to ensure tracking of projects, deliverables, and accomplishments.
• Liaise with and provide input/direction to Clinical Trial Regulatory Operations, Clinical Diagnostics, and other key stakeholders to ensure the associated diagnostic submissions are defined, executed, and the regulatory requirements are met and aligned with the global regulatory strategy of the medicinal product.
• Work in collaboration with stakeholders across the organization to deliver efficiencies in regulatory submissions and processes.
• Support development of internal processes and procedures related to implementation of diagnostic regulations.
• Support other functions to identify gaps and affect change, including modifying existing processes or creating new ones, to maintain business critical compliance.

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 to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree