Contraline

Compliance

• Develop and execute innovative regulatory strategies that maximize development efficiency and increase probability of approval.
• Serve as the primary regulatory contact with FDA for Contraline and other health authorities worldwide.
• Lead all regulatory aspects of product development from preclinical stages through commercialization.
• Provide strategic input when required into corporate planning, fundraising activities, business development transactions, and investor communications.
• Participate in nonpromotional and promotional review as the Regulatory Affairs representative.
• Build and scale the regulatory affairs function as the organization grows.
• Lead preparation for regulatory agency meetings including Pre-IND, Type B, End-of-Phase 2, and Pre-NDA/BLA interactions.
• Oversee preparation and submission of INDs, NDAs, BLAs, amendments, and global regulatory applications.
• Provide regulatory leadership for drug-drug combination products and drug-device combination products.
• Collaborate closely with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners.
• Evaluate emerging regulatory risks and opportunities and provide proactive mitigation strategies.
• Support diligence activities related to partnerships, licensing opportunities, and acquisitions.

Vice President, Regulatory Affairs

Operations

• Own sponsor-side pharmaceutical CMC strategy and decision-making from Phase 3 through commercial launch
• Serve as the company's single accountable leader for manufacturing strategy, regulatory CMC, commercial readiness, and lifecycle management
• Translate CMC gaps, risks, and regulatory expectations into practical execution plans with clear priorities, timelines, resources, owners, and decision points
• Prepare, review, and maintain clear, technically consistent CMC source documents and submission-ready materials
• Develop CMC strategies for key regulatory meetings and phase-transition decisions
• Lead technology transfer, manufacturing campaign planning, process validation, supply planning, and commercial readiness
• Assess CMC aspects of Business Development assets or potential acquisitions as required

Vice President, Regulatory Affairs

Vice President – CMC & Technical Operations