Director, Regulatory Affairs

The role

The Director of Regulatory Affairs develops and executes global regulatory strategies for Legend pipeline programs. This role represents Regulatory Affairs on global cross-functional teams and interacts with health authorities.

What you will do

• Develop and execute global regulatory strategies for Legend pipeline programs.
• Lead team efforts for the submission of INDs, CTAs, and BLAs and related supplements/variations.
• Evaluate the need to develop in-vitro diagnostic test or companion diagnostic tests.
• Oversee the maintenance of INDs, CTAs, BLAs, and ex-U.S. filings.
• Interface with the FDA and other health authorities to seek feedback and alignment.
• Serve as regulatory representative in global cross-functional development teams.
• Serve as regulatory representative in internal cross-functional teams for SOP development and business process improvements.
• Represent Legend regulatory affairs in external collaborations.
• Serve as the regulatory affairs reviewer in the promotional material review committee.
• Coach and mentor junior members on global project teams.

Required qualifications

• Pharm D or PhD Degree, or equivalent in a science or health care field
• Minimum of 7+ years of experience in regulatory affairs in drug development, focusing on filing and approval process in IND/CTA/BLA/MAA
• 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
• Excellent communication skills
• Strong organizational skills, including the ability to prioritize
• Strong interpersonal skills
• English

Nice to have

• Broad and in-depth knowledge of global regulatory requirements and regulations on drug development, experience in biologics and cell therapies
• Experience in cell and gene therapy
• Experience in drug development in multiple myeloma

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after three (3) months of employment
• Paid time off including vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives and peer-to-peer recognition programs

Before you apply

• Applicants must be authorized to work in the United States
• Employment eligibility will be verified through E-Verify

About the company

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances the next generation of cell therapy through a portfolio of innovative technologies.