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Director, Regulatory Intelligence


Collegeville, PA
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Job Details

Job Title Director, Regulatory Intelligence

JobID 1046455-1852

Location: Collegeville, PA

Description *About Pfizer*

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.

*Role Description*

This role's primary responsibility is to provide collaborative, industry leading, proactive and responsive strategic regulatory analysis to designated areas that provides privileged insight to inform Worldwide Safety and Regulatory (WSR) decisions and provide WSR and Pfizer a competitive advantage.


*Prioritization - In collaboration with leadership of designated areas, establish and maintain key intelligence priority lists that will drive specific upcoming intelligence activities.*Horizon Scanning - Systematically monitor the numerous Pfizer and publicly available information systems so as to collect and disseminate relevant, focused regulatory intelligence alerts and analysis on emerging issues and relevant events.*Analysis & Reporting-Provide strategic regulatory intelligence analysis to inform decision making in response to ad hoc queries from product teams, therapy areas, and other stakeholders.-Prepare periodic interpretive regulatory intelligence reports that analyze the strategic significance of recent past and forthcoming regulatory events and their potential impact on the Pfizer portfolio.*Collaboration-Collaborate with Category Area VPs, Reg Strategists, Reg Policy & Intelligence colleagues, and other Pfizer stakeholders to support policy activities at the product level, category area, and enterprise level.-Collaborate with other intelligence and policy organizations to provide context and broader perspective to increase the value of deliverables.-Establish and leverage internal and external networks to gather intelligence and insight that is not available from published sources. *Systems & Processes-Develop a working knowledge and understanding of relevant systems such as the Global Regulatory News, the internal Regulatory Intel website, and other internal and external tools, and leverage these tools to create, distribute and archive industry leading deliverables.-Lead or participate as assigned, in routine evaluations of new information sources, looking for both content usefulness and toward automating the process of collecting, disseminating, and archiving of regulatory intelligence for additional use.-Lead or participate in system and process improvement activities as assigned.


Education and Experience:* Minimum BA / BS in a scientific discipline, with an advanced degree preferred.* Minimum of 12 years of life science experience:*With at least 8-yrs in the regulatory field, that includes substantial experiences in product teams and interacting with Health Authorities.-Experience/knowledge in >1 region, and experience in an intel/policy/analyst role is beneficial.*Demonstrable knowledge of the drug lifecycle (research, development and commercial) process, and how the external environment can shape regulatory outcomes.Technical Skills:*Strong analytical skills. *Strong written and verbal communication skills.*Demonstrated abilities to perform strategic work.*Ability to effectively navigate, identify, extract, analyze, and communicate targeted intelligence from a wide range of external sources (e.g. subscription databases, health authority websites, etc.).*Competent posting to, organizing, and retrieving material from wide range of databases and web-based tools; proficiency in archival information systems (e.g. sharepoint)*Ability to evaluate utility of external resources for collecting regulatory & safety intelligence.*Customer focused and adaptable, with the ability to seamlessly balance and manage multiple projects from multiple stakeholders to time and quality.*High functioning as both a team player and individual contributor.*Ability to work effectively with Pfizer's internal and external vendors of information.*An understanding of applied principles of information storage and management including the use of internet/intranet based solutions.

*EEO & Employment Eligibility*

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.

*Director, Regulatory Intelligence*
*Collegeville, Pennsylvania*

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