This role supports primarily US licensed products.
The purpose of this position is to:
Create and deliver strategic regulatory guidance for assigned projects/products. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines
Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects.
Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
Direct and/or indirect liaison with regulatory authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
Lead and/or participates in Regulatory Teams for assigned projects/products.
Develop and implements regulatory strategies to support/maintain registrations. Maintains product licenses across all product platforms.
Understand regulatory environment and communicates priorities to global stakeholders
Deliver project /product strategy incl. label, risk assessment, and PRS for assigned projects/products
A Bachelor's Degree is required
5-8 years' experience in the pharmaceutical industry with combined experience in regulatory affairs
Other Job Details:
Last Date to Apply for Job: October 27, 2020
Additional Locations: Any USA Pfizer site
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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.