Pfizer (Regulatory Strategist)

Company Description
Pfizer - Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life.

Job Title: Senior Manager, Regulatory Strategist

Job Description
Create and deliver strategic regulatory guidance for assigned projects/products, with an appropriate level of independence and supervision.  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, strategies, labeling, submissions, 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 and products, including the preparation and submission of correspondence and applications to regulatory agencies.
Lead and participate in global, regional and in-country Regulatory Teams for assigned projects and products.
Understand  regulatory environment and communicate priorities to global, regional stakeholders
Deliver project, product regulatory strategy, risk assessment, and PRS for assigned projects/products
Developing or contributing to Global, Regional regulatory strategies and implementation plans including core labels, risk registers developed for assigned projects and products, with an appropriate level of independence and supervision. Generally assigned to projects of relatively moderate to significant scope or complexity.

Job Qualification

Job Experience
7-8 years

Job Category

Method of Application

Closing Date
11 May 2016

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