Pfizer - Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.
The PCO based Regulatory Manager for a country will lead, manage and provide strategic direction to develop and execute regulatory strategies and plans for the country and/or products under his/her responsibility, where applicable.
The PCO Regulatory Manager would represent Regulatory on the Country Manager Forum (CMF) 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.
Lead and manage the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Ensure to provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives.
Develop strong partnerships with in-country teams (e.g. Country Managers, Medical, Marketing, Supply Chain), Regulatory Clusters, Regulatory Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and lifecycle optimization.
Provide strategic contribution to the country (PCO) leadership team - anticipate what Regulatory needs to contribute to achieve business objectives.
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, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership. Face before the MOH authorities
Active participation in trade organization of country 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 of the countries that support 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. Influence on new sanitary legislation initiatives that could impact the business.
Technical Skill Requirements
Organizational Relationship(s) including to whom the position reports (JD Job Title):