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.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Regulatory Strategy and Execution
Ensure submission and approval of high-quality regulatory applications within planned timelines. Maintain clear metrics for Regulatory deliverables.
Preparation and support of new applications to obtain marketing authorizations.Voicing affiliate perspective and needs to global and regional regulatory contacts.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. Managing multiple regulatory submission preparation activities associated with electronic submissions. This will include providing compliance dossiers that meet China HA regulations. Completed the submission readiness documents preparations per agreed timelines. Ability to manage issue resolution and achieve goals. Responsible for coordination in submission planning meetings regularly. Tracking the electronic submission plans and discusses the status of ongoing projects with RA team, sets submission priorities where necessary and reports on project statuses to supervisor.Based on Chinese e-Submission/eCTD regulations and operations, well manage risk assessment and gap analysis ofactivities if required.Building up China electronic gateway submission management capabilityParticipate in the strategy formulation for e-Submission applications, share thoughts on e-Submission with the project team, and reach a consensus with the team.Regulatory Compliance
Ensure that internal Regulatory IT tools are up to date and accurate and actively use available tools to monitor regulatory plans.Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.Create, implement, and maintain local quality system in line with the global quality system and local regulations.Lead regulatory quality oversight of Third Parties (eCTD related) as appropriate.Process Improvement
Identify local process improvement opportunities and ensure implementation of relevant global regulatory initiatives.Consistently participate in affiliate cross-functional teams and provide regulatory status updates, input and knowledge.Ensure alignment and implementation of launch readiness initiatives.Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives to improve and maintain understanding of regulatory affairs within affiliate leadership.Managing Regulatory Operations by initiating WI/SOP and providing training to stakeholder and educating them becoming familiar with the submission process to achieve smooth submission readiness.Environment Shaping / Influence on regulatory agencies
Build partnership, mutual understanding & seamless collaboration with regulatory product managers, and/or content authors to provide guidance on submission preparation that meet both Lilly China internal requirement and China HA regulations.
Monitor dynamic regulatory environment and share the analyzed information within the team. Provide professional and prompt reaction to influence the agency and benefit the environment shaping.Continuous external stakeholder engagement to shape regulatory environment，contribute advice and suggestions to China HA regulations.Personal and Professional Development
Knowledge and understanding of local regulations and local, regional, and global regulatory procedures.Manage own performance and development by actively setting and meeting individual professional development goals.Attend appropriate external symposia, workshops, or conferences to develop and sustain an appropriate level of professional expertise.Minimum Qualification Requirements:
B.S, or above degree or equivalent experience.Prefer with major in Medical, Pharmacy or IT.Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge.Good experience within an electronic regulatory submission publishing system including hands on experience and broad industry standard systems knowledge.Working knowledge of business software, including MS Word, Excel, PowerPoint, Project/SharePoint, Adobe Acrobat Professional and Outlook.Experience with CTD/eCTD and publishing documents in Adobe Acrobat Professional. Experience in the preparation and submission of documents using regulatory/document management systems (e.g., VAULT®, Documentum®, Publishing Tools, and Validation tools) is required.Experience in the preparation and submission of documents using regulatory submission publishing systems (e.g., Publishing Tools like Insight Publisher, eCTD Xpress, or Lorenz) is required.Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.Familiarity with pharmaceutical development and global Regulatory submissions is required.Organized with systematic approach to prioritization; Process & result orientated to achieve the business objective; Ability to learn new technologies quickly.Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.)Be good at cross-functional communication and have mind set of teamwork.Other Information/Additional Preferences:
Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Ability to work independently under general supervision and adapt to changing priorities.Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions, or other experience related.Process orientated to achieve the business objective.Self-motivated and Innovative Capability of working independently
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