Director Regulatory Affairs, Clinical

The Director of Regulatory Affairs, Clinical reports to the Executive Director, Regulatory Affairs, and will manage the regulatory development and approval of drug products as well as establish and maintain compliance with global regulations and requirements.

PRIMARY JOB FUNCTIONS

• Responsible for developing global clinical regulatory strategies for development and late-stage programs
• Lead regulatory interactions with global regulatory agencies for development and late-stage programs
• Support the compliance of manufacturing (drug product and drug substance) and clinical development organizations
• Author and review key regulatory documents required for global drug product submissions such as responses to agencies’ requests, amendments, orphan applications, expedited development applications, etc.
• Ensure all approved and investigational regulatory applications are current and in compliance
• Interpret and apply global regulations, especially in ICH regions (US, EU, CA, AU, and Asia), and keep the team informed of the global regulatory environment by reviewing updated guidance
• Maintain regulatory compliance for global annual and periodic safety reporting
• Provide support to clinical development, commercial and business development functions as needed
• Author, edit, and review documents required for the establishment and maintenance of appropriate GxP systems within the regulatory affairs and compliance (Good Manufacturing, Good Laboratory, Good Clinical, and Good Documentation Practices)
• Participate in the design of CMC, non-clinical and clinical studies, review clinical protocols, pharmacy manuals, and related documents for regulatory submissions

ESSENTIAL QUALIFICATIONS & SKILLS

• Bachelor’s degree
• Must have knowledge and experience in global drug development, global regulations and guidelines and GXPs
• At least 7 years of experience in drug development regulatory affairs
• Experience and knowledge in oncology, cardiovascular disease, neurological and metabolic diseases are strongly preferred
• Experience in non-clinical development, manufacturing, and Quality Assurance is a plus
• Ability to work collaboratively and productively in a diverse, continually changing, and team-oriented organization
• Ability to work independently with internal and external stakeholders at various levels
• Excellent organizational, facilitation, and communication skills
• Self-motivated and able to work from a home office environment
• Demonstrated leadership capabilities and proactive problem-solver
• Practical knowledge of MS Word, Excel, PowerPoint, and project management software

OTHER REQUIREMENTS

• This role can be performed remotely from a home office in the US.
• Some long-distance travel (10%) may be required with a potential of travel occurring over weekends
• Flexible approach to time management with occasional work in evenings or over weekends as required