Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post: Global Regulatory Strategist
Job Description:
The purpose of this role is to provide:
• Accountability for development, management and implementation of development and post-authorization global regulatory strategies for specific project(s) 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 for assigned projects.
• Alignment of project regulatory strategy with business unit and regional needs.
• Management, leadership and coordination of virtual team of regulatory team members to deliver project objectives.
Responsibilities:
• Responsible for the development, updating and communication of global regulatory strategies for specified projects.
• Provides regulatory expertise and leadership for the project that accurately reflects the regulatory team inputs
• Member of appropriate Global Project teams accountable for the delivery of the Project goals according to the endorsed Regulatory Strategy.
• Responsible for ensuring that regulatory strategy will result in commercially attractive labeling.
• 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.
• Acts as the point of contact for all internal Pfizer communication regarding the status of the assigned Global project on issues related to regulatory process and registration strategy
• Ensures rapid reporting of key project/product regulatory milestones and/or issues to the WRSLT and PCH.
• Works with other members of WRS to ensure application of consistent processes and policies
• Identifies opportunities for process improvements, efficiencies and ‘better ways of working’
Qualifications (Training, Education, & Prior Experience):
• BS is required. BA will be considered combined with equivalent work experience.
• MS, PharmD, JD, or PhD/MD is preferred.
• Equivalent workplace experience will be considered.
• Should have demonstrable experience in managing regulatory process and regulatory deliverables of the dietary supplement development process and or regulatory commercialization activities including dietary supplements and OTC drugs.
• Should have demonstrable experience in leading matrix teams to achieve project deliverables.
• Previous experience in a Regulatory function for various products in different therapeutic area and in different stages of a products life cycle is desirable. Equivalent experience at a Regulatory Agency, R&D function or working on substantive industry-government collaborations will also be considered.
• Experience with global teams highly desirable.
Organizational Relationships:
• Under supervision by Global Regulatory Leader, Global Regulatory Strategist works with internal WRS team members as well as PCH R&D and business leaders to ensure alignment to the regulatory strategy with BU priorities
• Represents WRS as the single representative on global teams for assigned projects.
• Support local and regional Regulatory Team members in conducting external interactions including regulatory authorities (FDA, EU, MHLW, etc), professional scientific and regulatory groups, trade associations.
• Champions Global Regulatory Strategy Team for PCH WRS as appropriate. Partners with regional representatives through matrix, and ensures functional representation in GRST activities.
• Responsibilities will have a global perspective and require interactions with global team members.
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Resources Managed (budget and FTEs):
• Responsible to manage the virtual Regulatory team activities supporting the agreed regulatory processes and strategies over the entire life cycle of the assigned product .
• No direct report management responsibilities.
Additional Information
Experience: 1-2 Years
Education: MS, PharmD, JD, or PhD/MD
Job ID: 996057
Functional Area: DRA
Location: Australia; China; Hong Kong; India; Indonesia; Japan; Korea; Malaysia; New Zealand; Pakistan; Philippines; Singapore; Taiwan; Thailand; Viet Nam
Last Date: 30th May, 2014
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