Danielle Turner

Senior Director, Regulatory Affairs at Halozyme Therapeutics

Danielle Turner has over 18 years of work experience in various roles related to regulatory affairs and manufacturing in the pharmaceutical industry.

Danielle is currently working at Halozyme, Inc. as the Senior Director of Regulatory Affairs, a position they have held since October 2022. In this role, they are responsible for managing key regulatory activities, developing and implementing CMC regulatory strategies, liaising with partners and contract manufacturing organizations, and influencing in a matrixed environment.

Prior to their current role, Danielle worked at Takeda Pharmaceuticals (formerly Shire Plc.) as an Associate Director of Regulatory Affairs CMC from May 2017 to August 2019.

Before joining Takeda Pharmaceuticals, Danielle worked at Shire, formerly Baxalta. Danielle held the position of Manager of Regulatory Affairs (CMC) from October 2009 to May 2017. In this role, they implemented regulatory strategies, provided guidance and coaching for improvement of the change control process, and compiled and submitted regulatory documents.

Danielle's early work experience includes roles at Baxter International Inc. Danielle worked as a Validation Engineer II from December 2005 to October 2009, where they were involved in top facility projects and assisted in the scheduling and implementation of the requalification program. Danielle also worked as a Manufacturing Associate II from December 2003 to December 2005, where they assisted the supervisor in organizing and directing other team members and performed various manufacturing tasks.

Overall, Danielle Turner has a strong background in regulatory affairs, including CMC regulatory strategies, change control processes, and regulatory document management. Danielle also has experience in manufacturing and validation in the pharmaceutical industry.

Danielle Turner earned a Bachelor of Science (B.S.) degree in Chemical Engineering from UC Santa Barbara, attending the university from 1999 to 2003.

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Timeline

  • Senior Director, Regulatory Affairs

    October, 2022 - present

  • Director Regulatory Affairs

    September, 2019

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