● Lead, develop, and implement CMC regulatory strategies to ensure on-time and high-quality submissions for Drug Master Files (DMFs), marketing applications (NDA/ANDA), and post-approval lifecycle submissions.
● Perform critical review of all CMC documentation supporting regulatory applications, to ensure compliance with regulatory requirements and to effectively present data and strategy to regulatory agencies.
● Provide regulatory risk assessment for submissions, identify key risks to one-cycle review and approval. Develop mitigation and/or proactive response strategies.
● In concert with Regulatory Operations, ensure completeness and timeliness of eCTD submissions.
● Develop regulatory strategy and execute in the preparation of timely responses to CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities.
● Manage products and change control in compliance with regulations and company policies and procedures. Assess proposed manufacturing changes and provide regulatory guidance to enable regulatory and filing implementation.
● Lead or contribute to development of internal regulatory procedures and working instructions.
● Ensure proper CMC regulatory assessments and actions are taken for Field Alert Reports, or when product complaints arise during product lifecycle.
● Serve as a CMC Regulatory Subject Matter Expert, maintaining broad and deep knowledge of current and emerging regulatory requirements, e.g., FDA, ICH, EU. Analyze legislation, regulation, and guidance to provide awareness and impact assessment for the organization.
● Experience developing and implementing successful CMC regulatory strategies
● Extensive regulatory experience for both development projects and commercial products, with evidence of successful submissions to FDA, e.g., DMF, NDA, ANDA.
● Experience with sterile injectables within cGMP environment
● Strong experience with CTD format and content for regulatory filings
● Strong knowledge of eCTD elements and structure
● 15+ years pharmaceutical or industry related experience in R&D, or Manufacturing. 10+ years in Regulatory Affairs. Proven 3+ years in a leadership role with strong management skills.
● Demonstrated entrepreneurial abilities, organizational skills, strong verbal and written communication skills, attention to detail and can work with all levels of personnel including stakeholders
● Strong knowledge of drug development, and Current Good Manufacturing Practices (CGMP), as well as FDA, ICH, EU regulations and guidelines
● Ability to work in a cross-functional team environment with dynamic timelines and priorities
● Bachelor’s degree in pharmacy, biology, chemistry, engineering or related subject. Relevant advanced degree preferred.