Lilly (Sr.) Regulatory Affairs Manager, CMC in Bei Jing-北京, China
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 39,000 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.
Facilitate and support drug registration if necessary: Join drug registration strategy discussion by providing expert inputs related to CMC issues; facilitate RA team to solve the technical difficulties in drug registration; participate meetings with authorities (e.g. panel meeting with CDE) to facilitate CMC questions answer; as CMC expert, ensure good quality of CMC data in CTA/NDA submission. Provide support to CN RA colleagues to write CMC documents for submission as needed.
Solve general CMC issues for drugs: join discussion and strategy making for CMC issues which refer to all TA or multiple products based on global support. Solve the issues by good negotiation with the authority or environment shaping
Support CMC general projects initiated by authorities: support strategy making, communication and submission for any authority’s CMC general project, e.g. update specification for all Lilly China marketed products according to ChP
Support shaping regulatory environment: as Lilly drugs CMC representative, support regulatory environment shaping for CMC by joining RDPAC CMC working group and leveraging MOU project.
Minimum Qualification Requirements:
Strong scientific expertise relevant to CMC
At least 3-5year experience in drug development in global pharmaceutical company
Good command of English writing, speaking and listening skill
Be good at cross-functional communication and have mind set of team work
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!