Regulatory Manager, Ankara

Benefits

Additional Information

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Regulatory Manager - Ankara, Global Regulatory Affairs (GRA) Regulatory Manager- Ankara, Global Regulatory Affairs (GRA) - Regulatory Affiliate is accountable to support establishing the local regulatory strategy and plan for assigned product(s) in country, ensure local plan aligns to the global regulatory strategy and ensure local regulations and region/country business needs are included. The Manager is accountable to provide regulatory expertise in the delivery of high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s), and foster an environment of operational excellence in collaboration with cross-functional teams and provide influence to the local regulatory authority to successfully achieve regulatory objectives. The Manager is also responsible for Regulatory Policy and HA Relations and maintains the Regulatory activities at Ankara office Primary Responsibilities Effective Regulatory Plan Execution and Strategy Collaborate with the implementation of the regulatory plan in collaboration with GRA functions and affiliate cross-functions in alignment with affiliate business plans as well as regulatory requirements. Ensure submission and approval of high-quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables. Preparation and support of new applications to obtain marketing authorizations. Present affiliate's perspectives and needs to global and regional regulatory contacts. Ensuring timely responses to requests from support groups and/or Regulatory Authorities. Maintaining marketing authorizations (timely submission of post approval maintenance activities like renewals, variations and periodic reports) Effective collaboration with GRA Regional Regulatory Team supporting submission operational tasks to ensure high efficiencies of submission operations including planning process management, regulatory tools management, dossier preparation and product maintenance. Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally. Develop the regulatory plan. Actively participate in the affiliate launch teams, anticipating and delivering regulatory outcomes to support the affiliate launch plan. Represent the Regulatory Affairs function in New Product Planning discussions. Interact directly, or facilitate interactions with, regulatory bodies with effective communication and negotiation ensuring impactful influence. Voicing affiliate needs and perspectives to global and regional regulatory contacts. Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions. Represent Lilly in industry association meetings and workstreams related to regulatory strategy and harmonization. Regulatory intelligence - gather relevant information from local and global regulatory environments with potential local impact and for competitive advantage. Regulatory Compliance and Quality Partner with GRA Regional Regulatory Team supporting submission operational tasks to ensure the use of regulatory tools (e.g. Regulatory Information Management) for submission tracking and management and update of regulatory requirements are up to date/accurate and are actively used to monitor regulatory plans. Ensure that all products comply with local regulations and quality system requirements whichever is more stringent. Implement robust processes to keep regulatory archive complete and up-to-date and to ensure that all current licenses and labels are readily available. Ensure local quality system is in line with the global quality system and local regulations. Support regulatory quality audits and inspections and corrective and preventive actions as appropriate. Provide regulatory quality oversight for external parties e.g., regulatory affairs services providers, translators, graphic agencies as applicable. Perform assessment and communication of key regulatory compliance information to appropriate management and functions. Lead regulatory audits and inspections in collaboration with Regulatory Quality Organization. Lead and coordinate implementation of corrective/preventive actions. Lead regulatory quality over