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.