Director/Sr. director regulatory affairs
Company: Dendreon Pharmaceuticals LLC
Location: San Diego
Posted on: February 16, 2020
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
- 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
- Experience with post-marketing activities for commercial
product including labeling, advertising and promotional materials,
biological product deviation reporting, assessment of manufacturing
- 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
- 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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