Senior Director Regulatory Affairs

As our lead regulatory strategist, the Senior 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 cross-functional colleagues, the Sr. Director Regulatory Affairs will:
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
• Serve as primary liaison with FDA, and other global regulatory authorities.
• Review and interpret regulatory rules and guidance as they relate to company products and
procedures
• Ensure 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 (as needed) 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 7 years’ regulatory affairs experience or Masters’ Degree in
Regulatory Affairs and 5 years’ regulatory affairs experience within the biotech or
pharmaceutical industry
• Knowledge of global (US, EU, ROW, ICH, etc.) regulatory requirements
• Experience working on rare disease and ophthalmology programs, as well as recent successful
NDA submission experience is preferred