The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The purpose of the position is to lead regulatory affairs capability for a specific therapeutic category within Global Product Development. The incumbent would typically have the single point accountability for the Oncology Triad. The incumbent serves as a senior regulatory leader who has global mindset and expertise of drug development and product lifecycle processes and priorities, regulatory environmental issues, as well as commercial needs globally for all products and projects in the specific Category. The ultimate goal of the position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products so as to optimize input to development and commercial decision-making and ultimately lead to approvals with optimal labels for Pfizer products in GPD and WRD space, support marketed products at times of product defense activities and oversee more routine regulatory maintenance activities for products later in their life cycle.
The incumbent represents GRA on senior leadership committees and meetings within or across the different Pfizer Divisions. The remit is to appropriately represent the processes, policies and project/product deliverables of GRA as well as the processes and policies to represent the priorities of all regions within the global GRA department.
The Regulatory Global Head manages all the GRA staff within the Category regulatory team. In this role he/she ensures appropriate alignment of roles, responsibilities, and deliverables to the projects/products and to global GRA. This position balances priorities within and across regions, using load-sharing and job sharing, to assure qualified regulatory representation for each product or project, pre- or post-approval.
The Regulatory Global Head is accountable for ensuring that any site/region considerations for all projects and products are reflected in the relevant global regulatory strategy.
The incumbent is responsible for the effective communication and collaboration of the GRA groups and ensure that all regulatory deliverables are of high quality and optimally coordinated.
He/she conducts timely and efficient internal communication of resource and data quality matters, issues relating to the regulatory implications of emerging data, and implications of external regulatory environment changes to the SVP WW Medical Excellence and senior leaders within the Category and Triad.
The Regulatory Global Head is responsible for staff and talent management, career development and planning and performance management.
The Regulatory Global Head takes accountability for regulatory policy issues by making a commitment to represent Pfizer in appropriate scientific or regulatory activities (e.g., membership in internal advisory councils and/or external association) to influence the regulatory environment.
The incumbent has business management accountability as he/she needs to manage budget and costing structure for contribution of services of each BU.
He/she can serve as GRA Site Head for 1 primary site.
Represents GRA as single point of contact for the Category.
Convenes GRA leadership team assuring the establishment and maintenance of a collaborative performance oriented culture that embodies Pfizer Values and Leader Behaviors.
Owns global resource allocation to projects and product teams.
Participates as a GRA member in the development in global strategies and translates those into region and possibly site-specific deliverables.
Is responsible for global regulatory project/product governance, and global governance as appropriate.
Engages in appropriate activities in order to influence the regulatory environment.
May assume responsibility for other activities/functions within GRA as required.
Ensures development of all staff in BU or RU to help them achieve their full potential.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Approximately 15% travel
Other Job Details:
Eligible for Relocation Package
Additional Locations: New York, NY, Groton, CT, La Jolla, CA
Eligible for Employee Referral Bonus
Experience 15+ years with a BS/BA degree, 10+ years with an MS/MA or doctoral degree, or equivalent, with experience in drug development/commercialization and a record of continuous learning and education regarding regulatory processes and policies.
Regulatory experience - with drugs across life cycle, FDA Advisory Committee and other major Health Agencies’ hearings
Proven examples of drug development experience or other relevant experience within the Pharmaceutical industry/FDA/EMA.
Proven track record of successful management of staff and complex regulatory issues.
Proven business management capability
Internal Number: 4785738
About Pfizer, Inc.
Pfizer Global Research and Development (PGRD), Pfizer’s discovery and development division, is one of the finest pharmaceutical research institutions in the world. Our focus is clear - to discover and deliver an ever-increasing variety of medicines to significantly enhance the health and quality of life for people and animals around the world. We accomplish this with multidisciplinary teams of scientists and technology professionals who perform exemplary science, innovation and extraordinary teamwork.
Pfizer’s success is evident in our industry-leading pipeline of drugs. Our search for new treatments spans hundreds of research projects across 31 major disease groups and therapeutic areas - more than any other company on the globe. Included are oncology, anti-infective and anti-virals, central nervous system, cardiovascular, diabetes, obesity, and ophthalmology. Pfizer is responsible for many recognized drug breakthroughs that rank first in sales in their class, including several with which you may be familiar -- Lipitor (for high cholesterol), Zithromax (an oral antibiotic), Norvasc (for hypertension), and Viagra (for erectile dysfunction).