Sr. Manager- Regulatory Affairs CMC

7 days ago

Shanghai, Shanghai, China Eli Lilly and Company Full time CN¥1,440,000 - CN¥1,800,000 per year

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 Sr. manager, works together with regulatory project owners to facilitate registration, including CMC strategy making, technical communication, registration submission, CMC difficulities solving; support CMC head to handle general CMC projects and issues.

  • Facilitate and support drug registration: lead CMC strategy development, join drug registration strategy discussion by providing expert inputs related to CMC issues; 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. Prepara China specific CMC documents for submission.
  • 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 5-8year 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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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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