Regulatory Affairs Senior Manager

1 week ago

San Diego, California, United States Partnology Full time

Overview: A pioneering clinical-stage biopharmaceutical organization focused on the advancement of innovative cellular immunotherapies for patients suffering from cancer and autoimmune disorders is seeking an Associate Director in Regulatory Affairs. This role is pivotal in guiding and executing the strategic framework necessary for clinical regulatory activities that are critical for launching and managing clinical trials, as well as obtaining marketing approvals.

Key Responsibilities:

  • Engage in the strategic formulation and execution of clinical regulatory activities essential for the initiation and management of clinical trials and the pursuit of marketing authorization.
  • Facilitate communication with regulatory bodies such as the FDA, EMA, and PMDA to obtain scientific guidance and necessary approvals.
  • Lead cross-functional initiatives for global submissions, including the drafting and evaluation of IND/CTA, NDA/BLA/MAA, and other regulatory documents in compliance with local regulations.
  • Establish and implement departmental policies, processes, and standard operating procedures.
  • Provide regulatory oversight for due diligence and partnership activities, as well as product and company integrations.
  • Support the development of innovative systems and streamlined processes to ensure high-quality regulatory submissions and maintain a robust regulatory intelligence framework.
  • Ensure readiness for inspections related to regulatory activities and documentation.
  • Assist in the preparation of regulatory budgets and vendor management.
  • Stay updated on regulatory trends and operational practices.
  • Engage in technical discussions and collaborate with relevant groups at health authorities to advance regulatory science.

Qualifications:

  • Bachelor's degree in a relevant field with a minimum of eight (8) years of progressive experience; a Master's degree or PhD is preferred.
  • Proven regulatory experience in securing INDs and CTAs, as well as obtaining approvals for NDAs, MAAs, BLAs, and/or sBLAs.
  • Demonstrated success in contributing to effective health authority meetings.
  • Experience with breakthrough, RMAT, and orphan designation submissions; familiarity with companion diagnostic submissions (IDE/PMA) is advantageous.
  • Background in cell and gene therapy products or complex biological products.
  • Experience with autoimmune products and interactions with FDA CBER and EMA; additional oncology product experience is a plus.
  • Proven leadership in multidisciplinary teams to achieve cross-functional regulatory objectives.
  • Strong understanding of clinical and nonclinical regulatory science.
  • Knowledge of global regulatory submission standards and best practices in publishing.
  • Willingness to engage in hands-on regulatory tasks while simultaneously developing the department for future scalability.
  • Ability to influence and lead without direct authority.

Working Conditions:

  • Some travel may be necessary.
  • Position may require extended periods of sitting and standing, with vision monitoring and moderate noise levels.

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