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.

Play the role as CMC RA manager/Sr. manager, works together with regulatory project owners to facilitate registration, including CMC strategy making, technical communication, registration submission, CMC difficulties solving; support CMC head to handle general CMC projects and issues.

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 CHINA HA) 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 shapingSupport 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 ChPSupport shaping regulatory environment: as Lilly drugs CMC representative,  support regulatory environment shaping for CMC by joining RDPAC CMC working group and leveraging MOU project.

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Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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