Position Summary

Reporting to the Senior Director, Regulatory Affairs and Clinical Sciences, the Director (D), Regulatory Affairs drives the company’s regulatory strategies for BLA, IND, CTA, MAA, and NDS submissions in North America, Asia-Pacific (outside China), and EU. The Director, Regulatory Affairs is a key member of project teams and is responsible for strategic development and management of plans to bring to approval the cell therapy and other assets. The Director, Regulatory Affairs will bring knowledge regarding the development process and regulatory requirements, strong project management and vendor management skills, and excellent communication and writing skills to ensure that company submissions meet regulatory and company standards with high quality and within stated timelines.

Key Responsibilities

· Develop strategy and timelines for submissions, including dossier contents

· Work cross functionally with SMEs to ensure development and delivery of high quality submissions

· Ensure efficient and professional communication with FDA and other Health Authorities, as required, and support the leadership team with Health Authority meetings

· Support the submission and maintenance of INDs/CTAs in compliance with all relevant regulations

· Ensure appropriate archiving of assigned projects

· Interact with vendors to submit applications and reports to applicable regulatory agencies within established timelines and with high quality standards

· Support the implementation of new regulatory strategies, processes and SOPs

· Develop strong relationships with internal and external team members, ensuring positive interactions and driving shared commitments

· Perform other related duties, as assigned

Qualifications and Requirements

· MS degree or higher in science, with 10 years of relevant experience, PhD or PharmD preferred

· CAR T or other cell and gene therapy experience requested, oncology experience a significant plus;

· Strong organizational, problem solving, and project management skills

· Excellent written and verbal communication skills

· Ability to balances a sense of urgency with adherence to quality

· Strong leadership skills and understanding of cross functional interactions

· Strong professional research and writing skills

· Speaking Mandarin is a plus

· Some international and domestic travel is required

Supervisory Requirement

· None

Frequent Contacts

· Health Authorities

· Cross-functional Departmental Managers

· Vendors