Hengrui Pharma
Director of Regulatory Affairs
Participate in the company's global regulatory strategies for biologicals (including monoclonals, bispecifics, ADCs, fusion proteins, recombinant proteins, etc.) (especially US and EU filings). Lead team to communicate with FDA & EMA, as well as prepare FDA & EMA filing dossier including but not limited to IND/INDa/CTA/BLA/MAA and other filing types; participate in discussions on internal and external CMC issues, guide team to track the release and update of FDA & EU regulations and guidelines, to ensure the company's products can be approved in US and EU efficiently and compliantly, and actively promote the realization of the company's global business goals.
Responsibilities
Develop regulatory strategy: participate in the development of US & EU regulatory strategy and/or overall plans for the entire lifecycle of company’s biological products (from preclinical to post-marketing). Provide forward-looking regulatory guidance to CMC team to ensure that R & D and manufacturing activities comply with laws, regulations, guidelines and technical requirements in US & EU.
Communicate with HAs: lead biological CMC issues/dossier preparation, strategy development and communication in all meetings with FDA & EMA (such as Pre-IND, EOP1, EOP2, Pre-BLA, Scientific Advisory Committee Meeting, etc.). Lead to prepare all of response of FDA & EMA Information Request/ Clarification Request, etc.
Prepare biological CMC dossier for FDA & EMA application: lead team to prepare, review and deliver biological CMC application dossier with high quality (CTD, including but not limited to IND/INDa/CTA/BLA/MAA, etc.).
Cross-function collaboration: work closely with other internal departments of the company (such as non-clinical, clinical, medical, R & D, CMC, quality and medical affairs, etc.) and provide FDA & EU regulation to ensure the compliant advancement of projects in US & EU.
Regulatory intelligence and compliance: continuously monitor, analyze and interpret global regulatory trends related to biologicals, assess the impact on the company’s projects, and provide early warnings and recommendations to management.
Qualifications & Capability
Master’s degree or above in a pharmacy or biology-related field, with a solid foundation in CMC.
Familiar with US & EU drug registration process, with at least 10 years of regulatory experience in the pharmaceutical industry, including at least 5 years focused on biological pharmaceuticals. Should have experience leading and completing the entire US FDA biological registration application (BLA) process, as well as experience with EU EMA or other international market applications for biological.
Extensive experience communicating directly with the FDA & EMA.
Familiar with FDA & EMA regulations and guidelines related to biologicals, as well as the technical requirements for biologicals in all stages of R&D and manufacture.
Ability to lead team in the preparation and review of biologicals application dossiers (including but not limited to IND/INDa/CTA/BLA/MAA), and ensure comprehensively the quality of the application dossiers.
English should be working language; proficiency in English is required for the preparation and review of CTD pharmaceutical application dossiers for US & EU application, as well as for internal and external technical communication.
A high sense of responsibility and professionalism.
Possess excellent communication and coordination skills, teamwork skills, and the ability to analyze and solve problems, and be able to adapt to a fast-paced work environment.
Seniority level
Director
Employment type
Full-time
Job function
Research
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr
Responsibilities
Develop regulatory strategy: participate in the development of US & EU regulatory strategy and/or overall plans for the entire lifecycle of company’s biological products (from preclinical to post-marketing). Provide forward-looking regulatory guidance to CMC team to ensure that R & D and manufacturing activities comply with laws, regulations, guidelines and technical requirements in US & EU.
Communicate with HAs: lead biological CMC issues/dossier preparation, strategy development and communication in all meetings with FDA & EMA (such as Pre-IND, EOP1, EOP2, Pre-BLA, Scientific Advisory Committee Meeting, etc.). Lead to prepare all of response of FDA & EMA Information Request/ Clarification Request, etc.
Prepare biological CMC dossier for FDA & EMA application: lead team to prepare, review and deliver biological CMC application dossier with high quality (CTD, including but not limited to IND/INDa/CTA/BLA/MAA, etc.).
Cross-function collaboration: work closely with other internal departments of the company (such as non-clinical, clinical, medical, R & D, CMC, quality and medical affairs, etc.) and provide FDA & EU regulation to ensure the compliant advancement of projects in US & EU.
Regulatory intelligence and compliance: continuously monitor, analyze and interpret global regulatory trends related to biologicals, assess the impact on the company’s projects, and provide early warnings and recommendations to management.
Qualifications & Capability
Master’s degree or above in a pharmacy or biology-related field, with a solid foundation in CMC.
Familiar with US & EU drug registration process, with at least 10 years of regulatory experience in the pharmaceutical industry, including at least 5 years focused on biological pharmaceuticals. Should have experience leading and completing the entire US FDA biological registration application (BLA) process, as well as experience with EU EMA or other international market applications for biological.
Extensive experience communicating directly with the FDA & EMA.
Familiar with FDA & EMA regulations and guidelines related to biologicals, as well as the technical requirements for biologicals in all stages of R&D and manufacture.
Ability to lead team in the preparation and review of biologicals application dossiers (including but not limited to IND/INDa/CTA/BLA/MAA), and ensure comprehensively the quality of the application dossiers.
English should be working language; proficiency in English is required for the preparation and review of CTD pharmaceutical application dossiers for US & EU application, as well as for internal and external technical communication.
A high sense of responsibility and professionalism.
Possess excellent communication and coordination skills, teamwork skills, and the ability to analyze and solve problems, and be able to adapt to a fast-paced work environment.
Seniority level
Director
Employment type
Full-time
Job function
Research
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr