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A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Provide strategic regulatory expertise as Global regulatory representative to Product/Project Team(s).
Help coordinate virtual global regulatory strategy team (GRST), encompassing in country regulatory colleagues from North America, EMEA, APAC & LATAM as appropriate.
Through the GRST, develop, align, manage and implement the global regulatory strategy and
risk assessment including determination of regulatory probability of success and risk mitigations.
Be accountable for delivering the project goals and aligning the regulatory strategy with global and business regional needs as applicable.
Be accountable for timely submissions and approvals with commercially attractive labelling across the regions as applicable.
Be accountable for development of core dossiers for new multi-region projects as applicable.
Help ensure optimal regulatory interactions with Health Authorities in relation to the assigned project(s).
Project(s) assigned can be in development and/or at post-authorization stage.
Responsible for the production, updating and communication of global regulatory strategies, and regulatory probability of success for assigned projects/products.
Provides regulatory expertise and leadership to the Project(s)/Product(s) teams, ensuring that all regulatory development process commitments are clearly communicated, monitored and met.
In partnership with the Project/Product Team Leader, is accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy.
Ensures appropriate representation for Pfizer for the project/product with Health Authorities.
Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy
Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders
Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRL and other stakeholders as required.
BS/BA is required. MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.
10 years relevant experience.
Advanced knowledge of regulations across more than one region preferable.
Working knowledge of other regulations and their associated challenges for global development programs.
Direct experience with development & management of regulatory submissions for a major country and/or region(s).
Direct experience in communicating with major regulatory agency (ies) (i.e. FDA, EMA, CFDA, Japan), as well as participating in/leading interactions such as End-of-Phase 2, resubmission and scientific advice meeting(s).
Understanding of clinical trial design and management.
Understanding of GXP practices, including regulatory documentation quality processes.
Experience working in a highly matrixed, global and multi-site environment.
Track record of having supported at least one project of high complexity and provided strategic direction.
Experience within different product category areas and at different stages of products life cycle.
Knowledge of consumer healthcare products (drug, device, dietary supplement and/or cosmetic) development practice rules, regulations and guidelines – familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
Proven ability in developing and implementing regulatory strategy – understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs/MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations.
Communication skills – ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
Presentation skills – is effective in a variety of formal presentation settings; one-onone, small and large groups, with peers, direct reports and senior managers.
Negotiation skills – can negotiate skillfully in tough groups. Can be direct and forceful as
well as diplomatic. Gains trust quickly of other parties to the negotiations.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Full time in Madison. Some global travel may be required.
Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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 sci...entists 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).