Director/Senior Director, Regulatory Affairs, CMC

• Lead CMC quality execution of all CMC regulatory activities for biologics/gene therapy product development according to business priorities
• In coordination with CMC leadership team, define and implement the global CMC strategy for early health authority interactions through BLA/MAA registration
• Manage all CMC-related submission activities and oversees regulatory writing and timely delivery of high-quality technical documents including, briefing books, quality modules for clinical trial and marketing applications, drug master files, and responses to regulatory authority inquiries, while assuring all documents meet regulatory requirements and quality compliance
• Interact with colleagues in other departments, other R&D functions and RA functions to deliver high quality dossiers, documents and materials in accordance with business priorities
• Provide regulatory leadership on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives
• Work with local agents and experts in Brazil, European Union, Japan and other rest-of-world countries to develop regional CMC regulatory strategies
• Provide leadership in the support of the regulatory documentation system(s) to reach excellence to ensure efficiency, traceability and compliance of regulatory CMC documents
• Represents CMC RA at health authority meetings and/or CMC-related conferences
• Work with VP of Regulatory Affairs to identify resource needs, including consultants and new associates, advising on skills sets to meet needs
• Develop regulatory manager and/or associate to lead CMC submission writing activities and provide high quality documentation for regulatory submissions
• Coach regulatory manager and/or associate to provide regulatory advice to their cross-functional teams including requirements for product development and registrations
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives. We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
  • Bachelor's degree required, Advanced degree in biological sciences preferred.
  • A minimum of 10 years of experience in Regulatory Affairs, CMC Biologics (Bachelor's degree requires at least 12 years)
  • Preference for experience in CMC gene therapy development
  • Experience with global regulatory quality requirements
  • Demonstrated ability to manage competing priorities to deliver on-time and high quality regulatory documents
  • Skills to build technical excellence and process efficiency in CMC across functional teams
  • Proactive approaches to problem-solving with strong decision-making capability
  • Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and health authorities
  • Highly resourceful team-player, with the ability to also be extremely effective independently
  • Experience with preparation of high-quality FDA/EMA submission documentation and Health Authority meeting preparations preferred

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