Lead the analytical development and quality control strategy for oral solid dosage products, ensuring robust method lifecycle management and regulatory compliance. Partner with CDMOs to resolve complex analytical issues and author CMC sections for regulatory submissions.
The Vice President of Regulatory Affairs will lead the company's global regulatory strategy, overseeing both CMC and clinical regulatory activities from development through post-approval. This role serves as the primary liaison with regulatory agencies and is responsible for building and scaling the regulatory organization.
You will own the end-to-end marketing and communications strategy to build a new category of veterinary medicine and prepare for the launch of LOY-002. This includes defining messaging for both veterinary professionals and consumers while managing company-wide communications and pipeline promotion.
The Senior Statistician will lead the preclinical statistical strategy, including study design, power analysis, and mortality projection modeling. They will also serve as the primary statistical contact for R&D programs and contribute to regulatory data strategies for FDA approval.
