Director - PCH Regulatory Affairs - Pfizer - Madison

Job description
Role Description
* Accountability for development, management and implementation of development and post-authorization global regulatory strategies for specific project(s)/,products(s), and/or indications within the portfolio. This includes products for development/expansion for all regions/affiliates. .Accountability for submissions and approvals with labeling that achieve target claims and reflect available data.
* Accountability for ensuring regulatory interactions with Health Authorities occur in relation to the specified project(s) strategy
* Alignment of regulatory strategy with business unit
* Role may be combined with other Regulatory Strategy Roles (i.e. regional role or be RS for multiple projects)
* Lead and direct OTC switch programs

Responsibilities
* Responsible for the production, updating and communication of global regulatory strategies for specified projects, products, mechanisms of action and/or indications and where relevant, provides guidance to other regulatory counterparts on appropriate implementation

* Provides regulatory expertise and leadership for the project/product that accurately reflects the regulatory team inputs
* Member of appropriate Development and Commercial teams (e.g. GFT or switch) accountable for the delivery of the Project/product goals according to the endorsed Regulatory Strategy.
* Responsible for ensuring that regulatory strategy will result in commercially attractive labeling
* Ensures appropriate representation for Pfizer for the project/product with Health Authorities
* Ensures rapid reporting and dissemination of regulatory agency contact reports and project/product communications to appropriate leaders and colleagues
* Ensures that all regulatory development process commitments are clearly communicated and that all regulatory project performance measures are met or exceeded.
* Responsible for communicating resource estimates (both FTEs and dollars) to deliver on project objectives. Responsible for providing input and monitoring of regulatory line items in the project budget process.
* Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives
* Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders
* Ensures rapid reporting of key project/product regulatory milestones and/or issues to the WRSLT and PCH.
* Participates in appropriate governance committees, as necessary

Qualifications
* BS is required
* MS, PharmD, JD, or PhD/MD is preferred.
* Equivalent workplace experience will be considered
* Should have demonstrable experience in managing regulatory process and registration aspects of the drug development process and or regulatory drug commercialization activities including OTC drug/devices
* Previous experience in a Regulatory function for various products in different therapeutic area and in different stages of a products life cycle is highly desirable. Equivalent experience at a Regulatory Agency or working on substantive industry-government collaborations will also be considered.
* Experience leading teams required. Experience with Rx to OTC switch programs desirable

Technical Skill Requirements
* Has significant prescription and consumer experience in some or several therapeutic areas, through prior regulatory experience; direct product development and/or academic training
* Demonstrated knowledge of global regulatory procedures and requirements. Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs / CTAs and NDAs / MAA/IRDs.
* Strong problem identification and solving skills, e.g. risk management planning. Strong logical and analytical skills.
* Communicates effectively using a variety of mediums appropriate to the setting.
* Demonstrated understanding of project management and ability to implement and partner for successful milestone achievement.
* Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations

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