Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
Position Summary: Reporting to the VP, Regulatory Affairs/Quality Assurance, the Sr. Director, Regulatory Affairs will develop and implement global regulatory strategies in support of business objectives, and will ensure regulatory compliance with pre-and-post approval filing and reporting requirements.
Responsibilities: • Working in partnership with the Vice President, Regulatory Affairs/Quality Assurance:
o Develop and implement global regulatory strategies in support of business objectives o Ensure regulatory compliance with pre- and post-approval filing and reporting requirements
o Represent company RA at external meetings with FDA and other global health authorities
o Provide regulatory expertise and support for pre-clinical, CMC, and clinical areas for investigational products
o Provide global strategic regulatory leadership and guidance to project teams
o Ensure clinical, non-clinical, and CMC programs are designed and implemented to meet regulatory requirements
o Define regulatory expectations for program teams
o Develop strategies and drafts and/or reviews responses and other documents intended for submission to FDA and other global health authorities
• Perform as the back-up to VP-RA as primary liaison with FDA, and other global regulatory authorities.
Serve as the back-up/delegate to VP-RA, as needed, in other matters.
• Review and interpret regulatory rules and guidance as they relate to company products and procedures
• Ensure, through management and/or delegation, that content of regulatory dossiers meet format and content requirements applicable to specific health authority regulatory requirements
• Manage, or delegate the management of, the completion of documents and other assigned tasks within established timelines and with high quality - in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory guidelines, styles, and processes
• Lead the regulatory dossier submission process for Clinical Trial Applications (US, EU, Canada, etc.) and registration submission. Oversee the management of timelines, as needed, in conjunction with internal and/or external project management
• Provide overall leadership for the development of global regulatory submission documents
• Manage, review, and/or edit and ensure the quality of regulatory documents or sections of regulatory documents prepared by other writers (internal or external), ensuring adherence to standards
• Serve as primary author for key regulatory documents or sections of regulatory documents (primarily briefing documents, meeting requests, and specialty submission documents)
• Take initiative to suggest modifications to existing programs/plans and offer new ideas for the organization
• Recruit, train, coach, and supervise staff and provide oversight for regulatory consultants and contractors
• Support or lead non-project activities, as needed (ie, SOP/standards development, organizational initiatives) Competencies:
• Excellent verbal and written communication skills; ability to collaboratively influence across multiple functions within a matrix environment
• Strong negotiation and facilitation skills; ability to communicate sound regulatory advice based on regulations, as well as the business needs
• Demonstrated ability to apply knowledge strategically and operationally across projects
• Self-motivated and detail oriented with sound judgement and problem solving skills
• Ability to multi-task in a fast-paced environment with changing priorities
• Ability to work independently as well as part of a team
Requirements: • Bachelor of Science degree, and 10+ years’ regulatory affairs experience within the biotech or pharmaceutical industry
• A minimum of 7 years regulatory experience within the drug development and approval process in IND/CTAs /marketing applications
• Knowledge of global (US, EU, ROW, ICH, etc.) regulatory requirements
• Experience working on ophthalmology programs, as well as recent successful NDA submission experience strongly preferred
Internal Number: 001
About Stealth Bio Therapeutics
Stealth BioTherapeutics is an innovative biopharmaceutical company developing therapies to treat the mitochondrial dysfunction associated with genetic mitochondrial diseases and many common age-related diseases.
Our mission is to lead the development of mitochondrial medicine to improve the lives of patients with diseases involving mitochondrial dysfunction, an area of high unmet clinical need.