Senior Director - Global Regulatory Affairs - Consumer Healthcare - Pfizer - Madison

Job description
Role Description
*The Pfizer Consumer Healthcare (PCH) Global Regulatory Strategy Head will provide regulatory leadership and strategic direction for PCH's business and to global R&D in support of PCH franchise brands.
*The Global Regulatory Strategy Head will interface with other functional members of the PCH project teams (e.g. R&D Franchise, Commercial, Clinical, Medical Affairs, Safety, Supply Chain) to ensure flawless design and execution of regulatory franchise strategies.

*The Global Regulatory Strategy Head will partner with PCH WRS Regional Regulatory leads to ensure successful and timely execution of these strategies in all PCH markets.
*The Global Regulatory Strategy Head will be a member of the PCH WRS Leadership Team to drive continual improvement and flawless execution of regulatory accountabilities across PCH WRS.

Responsibilities
The Global Regulatory Strategy Head will have the following responsibilities:
Advise and lead the development of innovative global regulatory strategies for R&D Franchise across food and dietary supplements OTC medicines.
Provide regulatory assessments of internal and external Franchise opportunities.
Provide strategic insights and inputs to the global commercial leaders based on an understanding and assessment of the global regulatory environment
Help guide the preparation for key Health Authority meetings and negotiations in support of submission and approval of major franchise product registrations.
Help with the development of international dossiers for use in registration processes ex-US.
Partner with Regional Regulatory Leads to help direct the growth and professional development of regional and country RA team members.
Ensure full compliance with all government regulations and corporate policies including oversight of corrective actions for which the regulatory team is accountable.
Coordination and implementation of consistent standards and processes, as well as sharing of best practices across the PCH regulatory organization.

Qualifications
*Scientific Degree (advanced technical or medical degree preferred).
*Minimum 12-15years experience in Regulatory Affairs.
*Regulatory Experience with Consumer products required; additional experience in Rx Regulatory Affairs may be advantageous.
*Proven ability to manage complex regulatory issues.
*Demonstrable experience across drug development and commercialization lifecycle, with proven examples of contribution. Proven ability to consistently deliver to time, cost and quality standards.
*Regional regulatory experience including knowledge of and application submission processes and product life cycle management activities for various consumer product categories. Direct experience registering various types of products in multiple countries across multiple regions would be a distinct advantage
*Demonstrable experience of effective delivery of objectives in a complex matrix environment.

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