Regulatory Affairs managerSanofi

Accountable for Sanofi DIABETES product portfolio regulatory activities in the country. * Ensures the implementation of regulatory strategies and projects to obtain marketing authorization for new products and existing portfolio, having as ult Accountable for Sanofi DIABETES product portfolio regulatory activities in the country. Ensures the implementation of regulatory strategies and projects to obtain marketing authorization for new products and existing portfolio, having as ultimate goal regulatory compliant products to be commercialized according to business strategy. Responsible to interact with all the appropriate stakeholders to ensure compliance of the products according to regulatory requirements and Sanofi policies. In alignment with the regulatory Country Head, represents the Business Unit to the Food and Drug Administration of the Philippines (FDA). Ensures regulatory environment and requirements are well understood and considered in product business strategies. Accountable to ensure that regulatory activity is submitted and approved in due time. Develops relations with key regulatory authorities at a country level discuss issues and find solutions in the best interests of company. In alignment with regulatory Country Head and Diabetes Business Unit, analyses and communicates any changes in the regulatory area and liaises with pertinent Sanofi functions to ensure implementation of new ways of working. Works to ensure Sanofi DIABETES position in frontofFDA, aligning priorities with the regulatory Country Head and the different departments. As per need and upon delegation of the regulatory Country Head, be Sanofi's representative in pharma chambers / associations and ensure representation of company in Health Authority (HA) working groups / public consultations. Participates and contributes to the definition and implementation of strategies to prepare external regulatory environment to accommodate innovation. Provides regulatory expertise within the specific Business Unit's commercial teams, ensuring total compliance with legal requirements and ethical norms. Focal point for Regional / global regulatory product leads to discuss strategies for registration, submission and approval of new products and variations in the country. Ensures, in alignment with the regulatory Country Head, execution at local level of regulatory strategy to maximize attendance of commercial strategies. Collaborates with other Global regulatory function to ensuredossierssubmittedtothe FDA are maintained and updated in line with current regulatory standards and legal requirements. Manages portfolio rationalization activities, aligning Global regulatory objectives with affiliate objectives. Works to assureSanofiteamsgloballyarewellknowledgeableon FDArequirements (trainings and database updates). Manages team to support business needs within Sanofi DIABETES Business Unit: Promo and non-promo material approval, discussion and implementation of regulatory strategies, provision of regulatory input - trends and competitors intelligence - in Brand teams. Be responsible for regulatory risk assessment and management. Ensures Regulatory support for product crisis (shortages, discontinuation, counterfeit, recalls). Manages Regulatory budget following company processes and in alignment with regulatory Country Head. Acts in compliance with company directives and policies. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Monster

Philippines
Permanent
Full-time