Regulatory Affairs Senior Manager

2 weeks ago

San Diego, California, United States Partnology Full time

Company Overview: Partnology is a pioneering clinical-stage biopharmaceutical organization focused on advancing innovative cellular immunotherapies aimed at treating cancer and autoimmune disorders.

Position Summary: We are seeking a highly skilled Associate Director in Regulatory Affairs to lead and enhance the strategic planning and execution of essential regulatory activities for clinical trials and marketing authorization. This role requires significant collaboration with regulatory bodies such as the FDA, EMA, and PMDA, to secure scientific guidance and approvals.

Key Responsibilities:

  • Drive the strategic planning and execution of regulatory activities necessary for initiating and conducting clinical trials and obtaining marketing authorization.
  • Engage with regulatory agencies including the FDA, EMA, and PMDA to seek scientific advice and secure necessary approvals.
  • Provide effective cross-functional leadership for global submissions, including the authorship and review of IND/CTA, NDA/BLA/MAA, and other regulatory documents in compliance with local regulations.
  • Develop and implement departmental policies, processes, and standard operating procedures to enhance regulatory operations.
  • Lead regulatory efforts in due diligence, partnerships, and product integrations.
  • Support the creation and implementation of innovative systems and processes to ensure high-quality regulatory submissions and effective regulatory intelligence management.
  • Maintain readiness for regulatory inspections and audits.
  • Assist in the preparation of regulatory budgets and vendor management.
  • Stay updated on regulatory trends and operational practices.
  • Participate in technical discussions and collaborate with Health Authorities to advance regulatory science.

Qualifications:

  • Bachelor's degree in a relevant field with a minimum of eight years of progressive experience; a Master's degree or PhD is preferred.
  • Proven regulatory experience in clearing INDs and CTAs, as well as obtaining approvals for NDAs, MAAs, and BLAs.
  • Demonstrated success in facilitating health authority meetings.
  • Experience with breakthrough, RMAT, and orphan designation submissions; familiarity with companion diagnostic submissions is advantageous.
  • Knowledge of cell and gene therapy products and complex biological products.
  • Experience with autoimmune products and interactions with FDA CBER and EMA; oncology product experience is a plus.
  • Ability to lead multidisciplinary teams to achieve cross-functional regulatory objectives.
  • Strong understanding of clinical and nonclinical regulatory science.
  • Familiarity with global regulatory submission standards and best practices in publishing.
  • Willingness to engage in hands-on regulatory activities while building a scalable department.
  • Ability to influence stakeholders without direct authority.

Working Conditions:

  • Travel may be required.
  • Role may involve extended periods of sitting and standing, with moderate noise levels.

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