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Director/Sr. director regulatory affairs

Company: Dendreon Pharmaceuticals LLC
Location: San Diego
Posted on: February 16, 2020

Job Description:

Founded on the belief that immunotherapy made from a patient's own cells holds the key to the future of cancer care, Dendreon is making the battle against cancer personal. We are focused on improving the lives of men living with prostate cancer through the delivery of innovative immunotherapies that harness the power of the body's immune system to extend life. We're looking for talented people to join our team that will positively impact the lives of patients. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as a countrywide Commercial team, we have a diverse offering of exciting opportunities. Backed by Sanpower, a multi-national conglomerate, we are well-positioned for transformation and growth.The Dendreon Values: Rise to the Occasion - Challenge each other to do better every day. In every situation, there is an opportunity for excellence. Act As One - As one team with a shared purpose, we are strongest when we act together. Fight for What Matters - Our patients are counting on us. Their battle is our battle. Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today. Dendreon is seeking a Director/Sr. Director of Regulatory Affairs whom is responsible for leading and/or participating on interdisciplinary regulatory teams responsible for defining and implementing regulatory strategy, including plans to submit Marketing Applications globally. Provides regulatory leadership on cross-functional development teams.

  • Represents Regulatory Affairs on cross-functional development teams, providing regulatory strategy and support.
  • Leads preparation and oversees submission of meeting materials for FDA and other Global Health Authorities.
  • Assesses the impact of additions/changes to regulations and guidelines, and evaluates relevance to company and product interests.
  • Contributes to the development of department budget.
  • Leads multidisciplinary teams in the authoring of regulatory communications such as protocols, CSRs, Annual Reports to INDs /BLAs, CMC submissions, etc. A hands-on approach is vital.
  • Responsibilities include providing guidance, regulatory expertise, and advice to senior management and other company personnel to achieve goals for regulatory timelines, strategy, nonclinical and clinical testing.
  • Develops materials for, and leads key interactions with regulatory authorities.
  • Experience with post-marketing activities for commercial product including labeling, advertising and promotional materials, biological product deviation reporting, assessment of manufacturing changes, etc.
  • May or may not manage direct reports.
    • BS/MS/PhD in a scientific discipline with at least 10 years direct Regulatory experience in biotech or biopharmaceutical industry.
    • Prior clinical drug development experience
    • Pre- and Post-approval experience with advanced cellular therapy products is highly desired.
    • Typically 5 - 7 years leadership experience.
    • Knowledge of cGMP/ICH/FDA regulations.
    • Some travel required.

Keywords: Dendreon Pharmaceuticals LLC, San Diego , Director/Sr. director regulatory affairs, Executive , San Diego, California

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