Vacancies for Regulatory Affairs Head, PCO @ Pfizer
Role Description
• The PCO Regulatory Affairs Head will lead, manage and provide strategic direction and oversight to the Country based regulatory teams to develop and execute regulatory strategies and plans for the country and region, where applicable, in support of the Innovative BU (GIP, Onc, V).
• Represent WSR-I on the Country Manager Leadership Team (CMLT) and local Country Medical Council (or equivalent) to ensure collaborative connectivity with these key stakeholders (e.g. Commercial, Medical, etc), and a more focused regulatory approach to supporting country business objectives.
• Responsible for developing and executing regulatory policy and strategy in line with WSR and cooperate with Medical Managers and Medical Affairs Director in making of key business decisions in the process. Includes managing multidisciplinary and cross-divisional teams with regulatory guidance by applying a comprehensive knowledge and interpretation of regulatory requirements in consistent with commercial objectives and have responsibility to interact with external stakeholders for shaping regulatory environment.
Responsibilities
Lead and manage the local RA team in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Ensure that local RA teams provide strategic regulatory input into WRS global regulatory strategies, thus providing optimal support for meeting local business objectives.
Develop strong partnerships with in-country (e.g. Country Managers, Medical, Marketing, Supply Chain) and WSR Therapeutic Area and Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
Provide strategic contribution to the country (PCO) leadership team – anticipate what WSR needs to contribute to achieve business objectives.
Responsible for the development, leadership and performance management of the local RA team to achieve company objectives. Develop and enhance the capabilities and capacities of the RA teams through the identification and implementation of training and development needs.
Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product. Develop a long-term and positive relationship characterized by integrity, quality, compliance and leadership. Act in the capacity as the main liaison and primary contact for local government regulators with regards to all regulatory affairs related activities.
Active participation in local trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies and decision making. Positively influence local legislative initiatives that could impact the business.
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