Lilly Assoc. Regulatory Affairs Director in 北京, China
Type of Employment:
Play the role as CMC regulatory team leader to facilitate the CMC strategy and technical communication; Support RA team solving CMC difficulities; Coach CN RA colleagues in implementing the planned registration action when necessary; Lead strategy making, communication and submission for any NMPA CMC general project;Ensure CMC compliance with applicable policies, procedures and other regulations; Recruit, coach, and develop CMC regulatory staff with adequate eduation and experience to support the regulatory activities in China. Facilitate regular meetings with feedback and developmental discussions; assist in development of career plans; and ensure good succession planning.
Make CMC strategy for general requirements: lead discussion and make decision for general CMC requirements, e.g. build CMC documents templates, agline CMC variation strategy with global.
Recruit, coach, and develop CMC regulatory staff with adequate eduation and experience to support the regulatory activities in China. Facilitate regular meetings with feedback and developmental discussions; assist in development of career plans; and ensure good succession planning. Provide instruction to CN RA colleagues to write quality overall summary for submission as needed
Work as a China CMC advisor to support colleagues in CN RA colleagues, Global RACMC to develop CMC strategies as needed
Be accountable for improving RA colleagues’ capabilities: organize or provide CMC trainings and draft guidance discussion, shadow TA colleagues in order to ensure each TA clearly understand and excute CMC requirements.
Agency engagement: Take lead in efficient ommunication with regulatory agencies/institutes (e.g., NMPA, PFDA, CDE, NIFDC, CPC, Provicial Drug Testing Institute) to confirm the regulatory requirement and registration pathway especially for those items not clearly defined in the current regulation
Monitor, interpret and deliver updated CMC requirements:Be accountable for evaluating and interpret the new CMC regulations/guidance, regulatory changes/trends, and communicate with internal stakeholders under the direction of line manager. Timely communicate and update to global counterpart regarding China regulatory CMC requirement；
Shaping regulatory environment: as Lilly CMC representative, lead regulatory environment shaping for CMC by joining RDPAC CMC working group and leveraging MOU project.
Lead CMC general projects initiated by NMPA: Lead strategy making, communication and submission for any NMPA CMC general project, e.g. update specification for all Lilly China marketed products according to ChP.
Solve general CMC issues: Lead discussion and strategy making for CMC issues which refer to all TA or multiple products based on global support. Sole the issues by good negotiation with the authority or environment shaping.
Facilitate and support RA projects if necessary: Lead new product development strategy discussion by providing expert inputs related to CMC issues; Facilitate RA team to solve the technical difficulties in product 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
Strong scientific expertise relevant to drug development and CMC related guidance, Biology background is preferred
At least 8-year 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
Travel or shift requirements
Strong communication skills, both verbal and written
Strong knowledge of quality systems
Demonstrated ability to manage large global organizations
Project management experience
Req Id: 50029BR