Senior Manager, Regulatory Affairs

Ipsen 查看所有职位

  • 上海市
  • 长期
  • 全职
  • 13天前
Title: Senior Manager, Regulatory AffairsCompany: Ipsen (shanghai) innovation pharmaceutical Co., Ltd.About Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!For more information, visit us at and follow our latest news on and .Job Description:To be responsible for the regulatory activities in Ipsen China, including license maintenance, CDE meetings, CTA/ NDA submissions & approvalsLicense maintenance
  • Prepare LCM activities based on the annual plan by discussing with GRA TA/ Global Reg-CMC.
  • Discuss and align on the submission strategy.
  • Prepare submission dossier according to the latest regulation, and exchange with global Reg-CMC, GRA TA and other cross-functional teams to ensure the dossier can meet the requirements.
  • Responsible for requesting QC samples and importation, QC submission, follow-up QC testing, and addressing QC queries to ensure completion in time.
  • Proactively communicate with relevant stakeholders (e.g., local supply/ global supply/ manufacturing site) about the registration plan, current status, estimated approval and its impact on the artwork/ spec No., etc.
  • Follow up closely for the CDE technical review and ensure approval as planned.
  • Create and approve Artwork in GLAMS
  • Apply reference drug listing if needed.
New product/ new indication registration
  • Make registration plans, and regularly check with GRA counterpart to ensure the submission as planned
  • Responsible for the CDE meeting (pre-IND, Pre-NDA, etc.) preparation, submission and follow-up.
  • Actively participate in local and global project team meetings and provide regulatory support
  • Prepare submission dossier according to the latest regulation, and exchange with GRA TA and other cross-functional teams to ensure the dossier can meet the requirement.
  • Responsible for local QC testing and specification verification during the registration process to ensure completion in time.
  • Responsible for generic name application to get approved.
  • Responsible for applying expediated pathway, if meeting the criteria
  • Provide regulatory support during CFDI clinical trial site inspection
  • Fully prepare and participate in the overseas on-site inspection, including pre-inspection preparation, support during the inspection process, and follow-up and response to the inspection results
Launch readiness support
  • Product Packaging: Ensure that packaging content is checked according to registration requirements and timely completion of packaging production and revision confirmation
Others
  • Familiar with Ipsen systems to ensure regulatory compliance
  • Responsible for promotional and non-promotional material review in the system
  • Competitor intelligence
  • Quick learning on the new regulations and adjust if needed.
  • RA support in SC business/ medical and local cross-functional teams
To be responsible for the regulatory activities in Ipsen China, including license maintenance, CDE meetings, CTA/ NDA submissions & approvalsLicense maintenance * Prepare LCM activities based on the annual plan by discussing with GRA TA/ Global Reg-CMC.
  • Discuss and align on the submission strategy.
  • Prepare submission dossier according to the latest regulation, and exchange with global Reg-CMC, GRA TA and other cross-functional teams to ensure the dossier can meet the requirements.
  • Responsible for requesting QC samples and importation, QC submission, follow-up QC testing, and addressing QC queries to ensure completion in time.
  • Proactively communicate with relevant stakeholders (e.g., local supply/ global supply/ manufacturing site) about the registration plan, current status, estimated approval and its impact on the artwork/ spec No., etc.
  • Follow up closely for the CDE technical review and ensure approval as planned.
  • Create and approve Artwork in GLAMS
  • Apply reference drug listing if needed.
New product/ new indication registration * Make registration plans, and regularly check with GRA counterpart to ensure the submission as planned
  • Responsible for the CDE meeting (pre-IND, Pre-NDA, etc.) preparation, submission and follow-up.
  • Actively participate in local and global project team meetings and provide regulatory support
  • Prepare submission dossier according to the latest regulation, and exchange with GRA TA and other cross-functional teams to ensure the dossier can meet the requirement.
  • Responsible for local QC testing and specification verification during the registration process to ensure completion in time.
  • Responsible for generic name application to get approved.
  • Responsible for applying expediated pathway, if meeting the criteria
  • Provide regulatory support during CFDI clinical trial site inspection
  • Fully prepare and participate in the overseas on-site inspection, including pre-inspection preparation, support during the inspection process, and follow-up and response to the inspection results
Launch readiness support * Product Packaging: Ensure that packaging content is checked according to registration requirements and timely completion of packaging production and revision confirmationOthers * Familiar with Ipsen systems to ensure regulatory compliance
  • Responsible for promotional and non-promotional material review in the system
  • Competitor intelligence
  • Quick learning on the new regulations and adjust if needed.
  • RA support in SC business/ medical and local cross-functional teams
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.

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