Regulatory Affairs Senior Specialist
other
Information
Regulatory Lead for assigned Celyad Oncology CAR T cell pipeline projects
Develop and implement innovative global regulatory strategies for assigned projects.
Provide guidance to team on Regulatory CMC, Nonclinical and Clinical topics
Develop detailed regulatory project plans and timelines for assigned projects; identify critical path activities, risks, gaps and mitigations.
Organizing meetings, coordinate discussions and capture minutes as assigned.
Manage regulatory submissions and rapid responses to Health Authority questions according to required timelines; coordination with internal and external collaborators.
Effective communication of regulatory strategy and submission status to stakeholders.
Liaise with individual contributors and Subject Matter Experts to develop key messages and complete regulatory submission documents.
Write, prepare and review well-organized, scientifically sound regulatory documents.
Ensure accuracy, consistency, completeness and adherence to applicable requirements of regulatory submission documents.
Format submission-ready documents to meet eCTD publishing requirements.
Track submissions, archive correspondence, and maintain regulatory documentation.
Maintain knowledge of current regulatory landscape and competitive intelligence.
Review and interpret regulatory, clinical, scientific and other technical documents.
Represent Department at team meetings as assigned.
Represent Company as liaison with Health Authorities.
Mentor RA staff and cross-functional team members as needed.
Follow policies, procedures and checklists for submission processes and archiving.
Contribute to new internal documentation, SOPs and checklists as assigned.
Additional support with department and company objectives as assigned.
More info: https://celyad.com/contact-us/careers/
