Regulatory Affairs Senior Manager

1 week ago

San Diego, California, United States Partnology Full time

Company Overview: Partnology is a pioneering clinical-stage biopharmaceutical organization committed to developing groundbreaking cellular immunotherapies aimed at treating cancer and autoimmune disorders.

Position Summary: We are seeking an experienced Associate Director in Regulatory Affairs to lead and enhance the strategic planning and execution of regulatory activities crucial for the initiation and management of clinical trials, as well as for obtaining marketing authorization. This role necessitates significant collaboration with regulatory bodies, including the FDA, EMA, and PMDA, to secure scientific guidance and necessary approvals.

Key Responsibilities:

  • Lead the strategic planning and execution of regulatory activities essential for initiating and conducting clinical trials and obtaining marketing authorization.
  • Engage with regulatory agencies such as the FDA, EMA, and PMDA to seek scientific advice and obtain required approvals.
  • Provide cross-functional leadership for global submissions, including the preparation and review of IND/CTA, NDA/BLA/MAA, and other essential regulatory documents.
  • Develop and implement departmental policies, processes, and standard operating procedures to enhance regulatory compliance.
  • Offer regulatory guidance for due diligence, partnerships, and product integrations.
  • Support the creation and implementation of innovative systems and processes to ensure high-quality regulatory submissions.
  • Maintain readiness for regulatory inspections and audits.
  • Assist in preparing regulatory budgets and managing external vendors.
  • Stay updated on regulatory trends and best 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 with INDs, CTAs, NDAs, MAAs, and BLAs.
  • Demonstrated success in health authority meetings.
  • Experience with breakthrough therapies, RMAT, orphan designations, and companion diagnostics is advantageous.
  • Familiarity with cell and gene therapy products and complex biological products.
  • Experience in the autoimmune sector and interactions with FDA CBER and EMA; oncology experience is a plus.
  • Ability to lead multidisciplinary teams to achieve regulatory objectives.
  • Strong knowledge of clinical and nonclinical regulatory science.
  • Understanding of global regulatory submission standards and publishing best practices.
  • Willingness to engage in hands-on regulatory activities while building a scalable department.
  • Ability to influence stakeholders without direct authority.

Working Conditions:

  • Some travel may be required.
  • Position may involve extended periods of sitting and standing, with moderate noise levels.

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