Vice President, Regulatory Strategy

Role: Vice President, Regulatory Strategy leading global regulatory affairs for biotech, medtech, and specialty pharma clients, with a focus on their assigned therapeutic domains and the 505(b)(2) pathway. Responsibilities: develop and execute strategic regulatory plans aligned with corporate goals; advise on laws, regulations, and guidelines across key markets; manage relationships with regulators like FDA and EMA; oversee regulatory submissions, clinical development plans, and interactions with health authorities; support business development activities, including cross-selling services and marketing initiatives. Requirements: minimum BS/MS in a science field; 15+ years in regulatory affairs within pharma, biotech, or CRO sectors, including 7+ years in management; proven success in US and/or European regulatory submissions, INDs, and product approvals; experience in regulatory strategy development, client advisory, and stakeholder management. HighValue: extensive experience with US/EU regulatory agencies, IND submissions, and product approvals, especially in innovative and complex modalities or therapeutic areas. WorkSetup: not specified, likely hybrid or flexible given senior leadership role.