San Diego, California

Regulatory Affairs Manager

Developing Immunotherapeutics against incurable diseases.

San Diego, CA || On-Site

Permanent/Direct Hire

Job Description

This role is for a Global Regulatory Lead and will be responsible for developing and delivering innovative regulatory strategies for product development and approval primarily focused on the US and possibly foreign regulatory approvals. We are seeking an individual to provide strategic direction and guidance on US FDA regulatory requirements for assigned cell therapy and development programs, driving development strategies that lead to reliable submissions and timely product approvals. This function will also include tasks monitoring the clinical performances of CROs and work closely with foreign regulatory teams and produce adequate strategies based on experiences from the US developments.

POSITION RESPONSIBILITIES

  • Drive global regulatory affairs strategies and activities across assigned programs with a focus on US FDA developments.
  • Partner closely with cross-functional colleagues to articulate and translate nonclinical and clinical regulatory requirements into practical, strategic regulatory strategies and plans.
  • Identify and assess regulatory risks define strategies to mitigate such risks
  • Plan, write and review drug applications and submissions, as well as represent Regulatory Affairs with various internal departments to manage activities and coordinate in the preparation of regulatory submissions
  • Prepare for and support meetings with regulatory bodies
  • Build and maintain excellent relationships with relevant regulatory agencies
  • Monitor impact of changing regulations on submission strategies
  • Serve as regulatory subject matter expert throughout the products lifecycle

Minimum Requirements/Qualifications:

  • 3+ years pharmaceutical/biotechnology industry experience in Regulatory Affairs University degree required; advanced degrees preferred
  • Experience with filings in rare disease therapeutic products, breakthrough therapy designations, experience with cell therapy and IO mAb products highly desirable
  • Experience as lead regulatory representative for development programs required, with sufficient competence to lead development team through regulatory processes
  • Experience and comfort with a fast-paced small biotech company environment Knowledge and experience in interpretation of regulations
  • Experience in the preparation of major regulatory submissions and supportive amendments or supplements for early and late-stage development programs
  • Demonstrate excellent leadership and communication skills
  • Display deep expertise with guidelines, policy statements, etc., show organizational, and interpersonal skills

#ACRP #ClinicalResearch #RegulatoryAffairs



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San Diego, California

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