(Sr.) Regulatory Affairs Manager, CMC
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
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 53934BR.
Lilly is an EEO/Affirmative Action Employer and 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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