North America Regional Regulatory Head - PCH
Pfizer, Inc. - Madison, NJ
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- 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
- [+] More
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
