Vice President, Global Regulatory Portfolio Lead (GRPL) Obesity

ROLE SUMMARY

The incumbent serves as a senior regulatory leader who has a global mindset, expertise of drug development and product lifecycle processes, and priorities including: a track record of successful regulatory achievements in developing and gaining approvals for obesity products, a leading voice that has influenced regulatory issues associated with obesity development,  and evidence of prior role as senior level point person for addressing commercial needs globally for all products and projects in an advanced obesity pipeline. The ultimate goal of this senior level position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products so as to optimize input to development and commercial decision-making and ultimately lead to approvals with optimal labels for Pfizer’s portfolio of obesity assets in PRD, and as the portfolio advances to support marketed products at times of product defense activities and oversee more routine regulatory maintenance activities for products later in their life cycle.   

Key Accountabilities:

• Oversee the designated Portfolio at the governance, strategic and technical level  
• Be accountable for the Regulatory Strategies and effective Global Regulatory Sub Teams (GRST) working within the assigned portfolio, ensuring aligned regulatory positions in place and agreed that take account of regional needs 
• Provide strategic guidance to projects and products through regulatory strategists reporting to him/her.  
• Model strong leadership and project management techniques to provide leadership to the GRS teams, committees or work units to develop objectives, strategy, and tactical plans for the portfolio, assuring a global focus of goals, strategies and plans
• Responsible for developing collaborative working relationships with the regulatory authorities and influencing emerging regulatory/policies in general and particularly in the assigned portfolio/disease areas 
• Supervise US/EU regional regulatory strategist leads and/or Global Regulatory Leads (GRLs), and responsible for staff and talent development, career development and planning and performance management  
• Ensure regulatory deliverables in place and delivered to time, cost and quality for all projects in the portfolio (line plan/GRS/PRS/regulatory risks/labeling claims)
• Contribute to the IDMB Regulatory Leadership Team and drive the required culture and behaviors though the organization  
• Champion flexible approaches to ensure efficient and effective resource utilization
• Ensure learning embedded in the organization

ROLE RESPONSIBILITIES

The incumbent serves as the senior global regulatory representative within the obesity disease area, at the governance, strategic, technical, and portfolio level responsible for regulatory decisions.

• Provides regulatory expertise and leadership within the assigned portfolio, and other disease areas associated with obesity, as relevant
• Is responsible for developing and maintain an in-depth regulatory knowledge of the portfolio including current and emerging global guidelines and regulator’s latest thinking, relevant regulatory approaches and actions, and status of competitor products  
• Responsible for ensuring global regulatory strategies for all projects and products within the assigned portfolio, along with co-morbid disease areas associated with obesity, as relevant are developed and implemented  
• Partners with leaders in PRD, International and Commercial teams to develop strong global regulatory strategies for projects and products  
• Develops strong and positive working relationships with regulators, professional bodies, external experts and opinion leaders
• Brings in a depth of expertise to develop novel concepts and approaches to