Sr. Director Asset Regulatory Affairs Lead

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business.

Requirements

• Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations
• PhD or PharmD preferred
• Experience in the development of therapeutics for autoimmune neurology, renal or rheumatology conditions is preferred
• Prior experience working in rapidly growing pharmaceutical organizations is desirable
• A thorough understanding and experience with the development and licensure of biologic drugs for orphan and pediatric indications
• Demonstrated ability to coordinate the development of critical regulatory documents involved in the development and approval of medicines with a focus on FDA, EMA, and PMDA
• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization
• A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
• Track record of successful interactions with regulatory and health authorities
• You are a connector, building relationships and partnering across the organization to achieve the company goals

Benefits

• Comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits