Director, Regulatory Affairs

Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team based in Somerset, NJ. 

Role Overview

The Director of Regulatory Affairs is responsible for independently developing, coordinating and executing the global regulatory strategies. The Director will represent Regulatory Affairs on global cross-functional teams and provide oversight on regulatory strategy implementation for the assets. The Director will interact with health authorities to seek feedback and reach alignment on regulatory strategies; oversee activities for regulatory filings and ensure timely and high-quality submissions. The Director will also work closely with collaboration partner on a key asset.

Key Responsibilities

• Responsible to independently develop innovative, robust global regulatory strategies and ensure their efficient and effective execution for Legend pipeline programs.
• Lead the team efforts required for the submission of INDs, CTAs, and BLAs as well as related supplements/variations; ensure timely and high-quality submissions.
• Lead the effort to evaluate the need to develop in-vitro diagnostic test or companion diagnostic tests for pipeline programs as needed.
• Oversee the maintenance of INDs, CTAs and BLAs, and ex-U.S. filings as required.
• Interface with the FDA and other health authorities to seek feedback and alignment on pre-clinical and clinical development strategies.
• Serves as regulatory representative in global cross-functional development teams for pipeline programs; work closely with other line functions to ensure efficient execution of regulatory strategies.
• Serve as regulatory representative in internal cross-functional teams for activities such as SOP development, business process improvements, etc.
• Represent Legend regulatory affairs in external collaborations.
• Serve as the regulatory affairs reviewer in the promotional material review committee
• Coach and mentor junior members in their roles on global project teams.
• Have a good understanding of the competitive regulatory landscape in oncology, immunology and cell therapy.
• Provides regular and timely updates to management on the status of all pending applications and planned submissions as necessary.

Requirements

• A Pharm D or PhD Degree, or equivalent in a science or health care field is required.
• A minimum of 7+ years of experience in regulatory affairs in drug development, focusing on filing and approval process in IND/CTA/BLA/MAA.
• Broad and in-depth knowledge of global regulatory requirements and regulations on drug development, experience in biologics and cell therapies is preferred.
• Ability to independently formulate and lead the team to execute global regulatory strategies.
• Experienced in the preparation of major regulatory submissions, amendments and supplements in US and ex-US countries.
• Good understanding on CDx development.
• Able to think out of the box, formulate innovative regulatory strategies to speed up clinical development.
• Demonstrate excellent communication skills.
• Demonstrate strong organizational skills, including the ability to prioritize.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, clinical, and manufacturing representatives.
• Experience in cell and gene therapy is a plus.
• Experience in drug development in multiple myeloma is a plus.
• Language(s): English 

#Li-JR1

#Li-Hybrid