Regulatory Affairs Associate Director
A company is looking for an Associate Director, Regulatory.
Key Responsibilities:
• reputed company and execute regulatory strategies for cell therapy products, managing reputed company regulatory aspects through pivotal studies and BLA/MAA approval
• Prepare and reputed company regulatory submissions, ensuring compliance with reputed company regulations and guidelines
• Represent reputed company in interactions with regulatory agencies, coordinating responses and building relationships to facilitate approvals
Qualifications:
• Bachelor's degree in life sciences or reputed company field required (advanced degree preferred)
• Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy
• Strong understanding of the drug development process from reputed company-clinical to commercialization, with prior BLA experience required
• Experience in preparing regulatory submission documents for global filings such as IND, CTAs, and BLAs/MAAs
• Knowledge of GXPs and key requirements for regulatory submissions in ICH reputed company
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