North America Regional Regulatory Head - PCH

Pfizer, Inc. - Madison, NJ

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END DATE March 28, 2012

Job Summary

Company
Pfizer, Inc. Pfizer, Inc.
Location

Madison, NJ, US

Job Type
Regular
Job Classification
Full Time
Experience
not provided
Education
not provided
Company Ref #
300559300559
AJE Ref #
555550474
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Job Description

pThe Pfizer Consumer Healthcare North America Regional Regulatory Head will provide leadership, strategic direction & managerial oversight to the US & Canada based regulatory teams to develop & execute regulatory strategies & plans for the region. Additionally, the North America Regional Regulatory Head will represent RD within the region through matrixed involvement with regional technical &/or medical RD roles. The North America Regional Regulatory Head will interface with other function leads (e.g. RD leaders, Commercial, Clinical/Medical Affairs/Safety) to ensure collaborative connectivity with these key stakeholders, & a focused regional regulatory approach to supporting country & regional business objectives.br /br /Organizational Relationships:br /The Regional Regulatory Head for PCH will be a direct report to Vice President, Worldwide Regulatory Strategy for PCHbr /br /Leader of Regional Regulatory Affairs Team, with US & Canada Regulatory Strategy team members as direct or indirect reportsbr /br /Member of the US Commercial Leadership Teambr /br /Resources Managed (budget & FTEs):br /4-12 direct reports (including PCO based Regulatory Managers & regional staff) br /br /strongResponsibilities /strongbr /The North America Regional Regulatory Head will have the following responsibilities: br /Delivery to the regions of innovative & beneficial consumer healthcare products with competitive claims in a timely manner.br /br /Strategic leadership of consumer product development & registration projects to meet the regional business objectives for the region.br /br /Full compliance with all government regulations & corporate policies including oversight of corrective actions for which the regional regulatory team is accountable.br /br /Coordination & implementation of consistent st&ards & processes, as well as sharing of best practices across the region & across the PCH regulatory organization.br /br /Direct the growth & professional development of the regional & country (US & Canada) Regulatory Strategy team members, including succession planning for critical roles within the regional & global regulatory leadership.br /br /Direct working relationships with the regional medical & technical RD associates assigned within the region.br /br /Accountability for regulatory capacity & capability management across US & Canada.br /br /Single point of contact for integration of Regional, Country & Business Unit regulatory activities.br /br /Oversee the development of strong working/partnering relationships with key agencies in the region, usually working through the local country regulatory managers. br /br /Be a recognised regional partner for other regional focused business activities & initiatives, including licensing opportunity considerations, innovative regulatory strategies, & regional/country talent management. br /br /strongQualifications /strongbr /Scientific Degree (advanced technical or medical degree preferred).br /br /Minimum 8-10 years experience in Regulatory Affairs.br /br /Regulatory Experience with Consumer products required; additional experience in Rx Regulatory Affairs may be advantageous.br /br /Proven ability to manage complex regulatory issues.br /br /Demonstrable experience across drug development & commercialization lifecycle, with proven examples of contribution.br /br /Proven ability to consistently deliver to time, cost & quality st&ards.br /br /Regional regulatory experience including knowledge of & application submission processes & product life cycle management activities for various consumer product categories.br /br /General management experience with line management & leadership at senior management level is essential.br /br /Demonstrable experience of effective delivery of objectives in a complex matrix environment.br /br /br /span style=text-decoration: underline;Technical Competencies/span:br /Underst&ing of regulatory agency philosophies & guidelines

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