Regulatory Affairs ManagerGandiva Insights • San Jose, California, USA
Regulatory Affairs Manager
Gandiva Insights • San Jose, California, USA
9 days ago
Job type
- Full-time
Job descriptionThe RNC Manager responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Regulatory Nonclinical / Clinical Lead and may include the following : Support the development of the nonclinical / clinical regulatory strategy and plan. Assist with selected planning document development and meeting execution activities in preparation for HA meetings / interactions. Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead. Collaborate with CROs that are contracted to perform regulatory submissions / HA interactions for global clinical trials. With oversight by RNC lead develop and coordinate the core nonclinical / clinical content of regulatory submissions. Responsible for ensuring high quality nonclinical / clinical content that adheres to regulations and guidances. Lead the maintenance of IND / CTAs throughout the life of the studies (e.g. annual reports) Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols Annual Reports Briefing Books etc.) and completing regulatory documents / forms for internal review. Collaborate with Reg PM to create and align submission timelines Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA. Oversee the collaboration of Nonclin / clin with Reg Ops to provide final documents and QC published outputs for submissions to HA. Organize and maintain the administrative nonclinical and clinical portions of INDs NDAs and BLAs. Oversee the archiving of HA submissions and correspondence Commercial Stage Product Lead the development of updates to the clinical and nonclinical sections of the core dossier used for INTL marketing applications. Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions examples are : clinical or nonclinical supplements to approved US product dossiers and any required annual reports license renewals supplemental filings. Coordinate necessary interactions with INTL in support of INTL MA filings. Examples include : meetings to provide RNC guidance / input on agency interaction submissions RTQs. Attend relevant functional area and project team meetings. Review understand and stay up to date on regulations guidelines relevant to responsibilities Review documents (SOPs protocols and reports) related to Clinical or Nonclinical studies as necessary Ensure that the PM timelines and tracker accurately reflect submission plans
Title : Regulatory Affairs Manager
Remote
USC or GC
Description :
- The Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulatory strategies through a programs lifecycle.
- The Manager leads the execution of delegated activities including preparation for HA interactions and the preparation of regulatory submissions in support of the strategy.
KEY RESPONSIBILITIES :
Development Stage Product
General
EDUCATION AND EXPERIENCE
Degree in health or life sciences including chemistry molecular biology or similar. PhD preferred Masters / Bachelors acceptable with relevant experience
Nonclinical / Clinical Regulatory Affairs experience preferred
Key Skills
Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills
Employment Type : Full Time
Experience : years
Vacancy : 1
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Regulatory Manager • San Jose, California, USA
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