Regional Regulatory Hub Strategist page is loaded Regional Regulatory Hub Strategist Apply locations Malaysia - Kuala Lumpur APAC - Any Pfizer Site Philippines - Manila Thailand - Bangkok time type Full time posted on Posted 5 Days Ago job requisition id 4906437 Job Summary: Single point of contact for GRS-IRSP Asia at regional regulatory level to develop and manage product-related registration strategies in the assigned therapeutic categories/countries. Apply knowledge and interpretation of regulatory requirements in the assigned countries to the drug development, registration and liefecycle management process. Drive Asia considerations/inclusion in the clinical and development strategies of the organizational pipeline. Expedite commercialization of new products, new indications and line extension as well as ensuring supply and business continuity within Asia region by providing early regional regulatory inputs to identify barriers and needs to shape global developmental/remediation plan. Effectively engage with relevant partnerlines (regulatory, commercial, medical, supply etc. including functional lines at global/regional/country levels) to deliver efficient and successful product development, registration and lifecycle maintenance strategies consistent with the region's commercial objectives. Ensure clear and timely communication/clarity of regulatory timelines and strategy. Ensure adherence to regulatory processes and regulatory documentation (as assigned accountability and responsibility identified in the organizational SOP) for self and team. Qualification
Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential. Appropriate Regulatory Experience – minimum 3 years experience (Job Grade specific). Experience at Regional level will be preferred. Proven ability to manage complex regulatory or drug development issues. Proven ability to consistently deliver to time, cost and quality standards. Proven ability to work effectively in a team and independently in a fast-paced environment, both proactively and reactively in a timely manner. Proven project management, strategic planning and creative thinking capability. Proven performance track record - country and/or regional. Country/regional knowledge (Asia and Global regulatory requirements). Fluent in English – written and spoken communication skills. Attitude: Growth mindset, Change-agile, Strong Team Player, and seeks Process Improvement.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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