Executive Director Regulatory Affairs Strategy

Summary/Scope: A multifaceted Regulatory Affairs Team Leader role. Will be a key member of regulatory leadership to ensure the development, implementation and alignment of US/ ex US regulatory strategy across projects within Retina / Ophthalmology. Will represent the regulatory affairs function as a Core Member of Project Teams and be responsible for developing and implementing regulatory strategy (US and/or global) to achieve regulatory approvals and competitive product labels. Core Responsibilities: With VP Regulatory Affairs, lead the development and maintenance of Regulatory Affairs practices and procedures at Ocular Therapeutix Responsible for preparation and compilation of domestic and international product submissions. This may include, but is not limited to: INDs, NDAs, MAAs, NDS and global CTAs. This also includes all lifecycle maintenance filings necessary to support these applications (e.g. CMC supplements/notifications, 2253 submissions, annual reports, efficacy supplements and safety reporting). Co-develop and direct implementation of global regulatory strategy for assigned projects, along with company representatives and other Regulatory and CMC staff. Guide regulatory staff in the development and implementation of regulatory strategy, submission strategy, and lifecycle management to ensure alignment with project team objectives (US and/or global). Communicate FDA feedback, regulatory strategies and plans to management, cross-functional teams and any partners/collaborators to establish alignment. Act as a strategic partner in the core governance & program teams within the company. Maintain knowledge of US competitive landscape, regulatory environment, regulations and guidances. Assesses the impact of new health authority guidances and provides insight and recommendations on Regulatory Policy & Intelligence Responsible for creation and maintenance of Regulatory Development Plans and submission strategies to achieve regulatory approvals that meet project needs. Lead the preparation of high quality regulatory dossiers ensuring compliance with regulatory requirements Ensure agency establishment registrations and device/drug listings are completed on time. Assist with the preparation and compilation of regulatory information requested during regulatory inspections. Support domestic and international field corrective actions and adverse event reporting, when necessary Other/Related Responsibilities: Responsible for leading, managing, mentoring, and developing regulatory staff. Direct responses to Health Authority inquiries as needed. Review product and process documentation for assigned projects to ensure compliance with regulatory dossiers. Responsible for the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes. Provide regulatory research information as requested. Develop, review and secure necessary approvals on key documents before major regulatory submissions (US and/or global). May participate in Business Development/Strategic Alliances efforts. Lead or participate in regulatory sub-teams, FDA and other Health Authority meetings for a project, as required. Prepare management and team for FDA and other Health Authority meetings, as required. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances Key Requirements: Solid scientific background, minimum Bachelors in scientific discipline. Advanced scientific degree, M.S. PharmD, PhD., M.D., preferred Minimum of 15 years pharmaceutical industry experience, of which 10 years in US and global regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting. Regulatory experience in multiple phases of drug development with deep expertise in Retina/Ophthalmology preferred. Demonstrated experience in strategic planning, preparing and leading IND/NDA submissions In depth knowledge of current US and global regulations and guidances essential as they relate to the overall global regulatory strategy Results driven and team-orientated with the ability to influence outcomes as necessary skills in the regulatory environment.