This position is responsible for the quality strategy for Horizon products (commercial and/or development), including testing and stability strategies. This position is also responsible for coordinating all aspects of CMC regulatory submissions and representing the function of CMC regulatory on multiple project teams as well as serve as the regulatory CMC liaison with partners on development and/or commercial products.
- Develop and implement CMC regulatory strategies for investigational and/ or commercial drug products
- Lead activities, including planning, writing and reviewing CMC sections of regulatory submissions (IND’s, NDAs, MAA’s, briefing documents) to support clinical trials and product registration.
- Coordinate preparation of responses to regulatory agencies
- Member of CMC Development Teams providing Quality input for development and/ or commercial products
- Collaborates with Manufacturing Operations to develop and approve strategies product lifecycle strategies
- Assess post-approval changes for existing commercial products to include impact assessment, tracking and implementation to ensure compliance
- Monitor ongoing regulatory commitment from a quality perspective including specifications, stability, etc.
- Quality approval for GMP documentation associated with manufacturing of product including methods, specifications, protocols and reports.
- Management of regulatory CMC documentation to support regulatory submissions and product transfers, as required (e.g. methods and specifications)
- Partner with Manufacturing Operations and Supply to identify and/ or quality establishments for the development, manufacture, packaging and testing of clinical and/or commercial products (drug product and API) including participation in quality audits.
- Scientific degree (minimally BA/BS) in Chemistry or Pharmacy
- 15+ years of CMC experience within development/ operations facility. Periods in Quality or Product Development function is considered advantageous
- Thorough knowledge of the Pharmaceutical Development and approval process
- Knowledge of multiple pharmaceutical dosage forms would be considered advantageous including API manufacturing
- Good knowledge of GMP requirements
- Knowledge of regulatory requirements associated with CMC development and clinical trial materials
- Demonstrated ability to work and draft documents in a fast paced environment
- Flexible with respect to prioritization of tasks and projects according to internal and external influences
- Excellent written and verbal communication skills
- Demonstrated organizational and project management skills
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- Instills Trust