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    4 days ago

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Associate Director/Director of Regulatory Affairs

1 month ago

Rockville, United States Medix™ Full time

Key Responsibilities:

  • Collaborate with cross-functional teams to develop and implement regulatory strategies, manage regulatory risks, and ensure compliance with current regulations for cell therapy products.
  • Prepare and manage regulatory submissions (INDs, CTAs, BLAs/MAAs) to agencies like the FDA and EMA.
  • Ensure quality and accuracy of regulatory submissions, adhering to timelines and requirements.
  • Supervise CROs/vendors handling regulatory submissions.
  • Integrate Health Authority feedback into global nonclinical and clinical development strategies.
  • Assist in planning and preparing clinical and non-clinical strategies for global HA meetings.
  • Review and provide feedback on company-sponsored abstracts, manuscripts, and publications.

Qualifications:

  • Bachelor's degree in life sciences or related field (advanced degree preferred).
  • 7-10 years of regulatory affairs experience in biopharmaceuticals or cell therapy.
  • Knowledge of US FDA and international pharmaceutical regulations, drug development processes, and industry practices.
  • Experience with early-stage development and marketed products preferred.
  • Familiarity with GXPs and regulatory submission requirements in ICH regions.
  • Preferred experience in hematology, blood coagulation, or platelet cell biology.
  • Experience in biotech or startup settings preferred.
  • Strong communication, negotiation, and leadership skills.