Exec Director/VP Regulatory Affairs

The role

The Executive Director or VP, Regulatory Affairs will lead regulatory strategy for defined disease areas. This includes developing and executing global regulatory strategies and submissions from pre-IND through product lifecycle management.

What you will do

• Represent regulatory on program and study teams
• Develop regulatory strategies to ensure development plans comply with regulatory requirements
• Lead or support preparation and review of regulatory documents
• Act as Regulatory Affairs representative in business development and due diligence activities
• Review relevant clinical documents for scientific content and regulatory compliance
• Act as primary liaison with the FDA and OUS health authorities
• Plan and direct regulatory activities through regulatory staff and cross functional teams
• Provide regulatory support for company compliance initiatives
• Provide regulatory support and guidance for regulatory audits and/or inspections
• Provide regulatory oversight of service providers and regulatory consultants

Required qualifications

• Undergraduate degree
• 10+ years of relevant experience in pharma or biotech regulatory affairs
• Deep expertise in global regulatory strategy from pre-IND through NDA and post approval
• Proven knowledge and experience in US and EU regulatory affairs
• Experience leading formal interactions with health authorities
• Proven knowledge of FDA and ICH guidelines
• Ability to translate regulatory requirements into practical workable plans
• Strong organizational skills
• Effective interpersonal, communication and influencing skills
• Excellent writing skills
• Experience leading, mentoring, and developing direct reports
• Ability to achieve high-performance goals and meet deadlines in a fast-paced environment

Nice to have

• Advanced degree
• Experience with NDA submission and product approval
• Experience with expedited programs for serious conditions such as FastTrack, Breakthrough Therapy Designation, PRIME

Benefits

• Paid Time Off
• Holiday
• Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Accounts (FSA, HSA, and Commute)
• Critical Illness and Accident Coverage
• Pet Insurance
• Employee Assistance Program
• 401(k) Plan with Erasca contribution
• Employee Stock Purchase Program

About the company

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer.