Manager/ Senior Manager US Regulatory Strategist Job in New York, New York US
Manager/ Senior Manager US Regulatory Strategist
The purpose of this position is to: Create and Deliver the regulatory strategy that aligns with business needs Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies. Act as direct liaison with regulatory authorities to facilitate the prompt review and approval of applications. Lead and/or participates in Regulatory Teams for assigned projects/products. Develop and implements regulatory strategies to support/maintain registrations. Maintains product licenses across all product platforms. Understand regulatory environment and communicates priorities to global stakeholders Deliver project strategy, risks, label and PRS Organizational Relationships : Reports to Global Regulatory Portfolio Lead Works with internal WWRS groups and relevant project teams. In addition works with relevant development/commercial team representatives within the PGS, and RD ( Worldwide Safety Operations and Risk Management, Worldwide Safety Sciences, Medical, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal). Resources Managed (budget and FTEs): Contributes to relevant parts of the Department budget (e.g. travel, training, pay and reward) and responsible for meeting financial targets Locations: New York, NY; Groton, CT Responsibilities The major duties and responsibilities will include but are not limited to: Accountable for ensuring or contributing to Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s. Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities. Partners with project teams and other customer groups (e.g. Country Regulatory Managers and Brand Teams) to ensure required regulatory contributions (line plans, IND, NDA) meet business needs and are provided to the project teams, to agreed time, cost and quality standards. Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated Ensures an aligned regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated. Works closely with other Regulatory Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning's and quality standards. Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines. Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate. Ensures business compliance and implementation of and adherence to Regulatory standards. Develops and maintains constructive working relationship with Health Authority contacts. To be considered for this position, please directly apply at www.pfizercareers.com and search for job opening 963363.