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Regulatory Affairs Manager
Regulatory Affairs ManagerGandiva Insights • San Jose, California, USA
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Regulatory Affairs Manager

Regulatory Affairs Manager

Gandiva Insights • San Jose, California, USA
[job_card.30_days_ago]
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  • [job_card.full_time]
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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 :

  • The 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 :

    • Development Stage Product

  • 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.

    • General

  • 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

    • 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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