Sr. Manager of Regulatory Affairs, Biologicals and Chemicals
Thermo Fisher ScientificSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
- Strong scientific expertise relevant to CMC
- At least 5-8 years 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
Responsibilities
- 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 difficulties 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; prepare 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
Skills
CMC Regulatory Affairs
Regulatory Strategy
Drug Registration
NDA Submission
CTA Submission
Authority Negotiations
China HA Meetings
RDPAC
CMC Documentation
Specification Updates
Eli Lilly and Company
Develops and delivers prescription medicines globally
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees