The Global Regulatory Franchise Lead - Ophthalmology will be responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities. They will also represent the company with domestic and international regulatory authorities, contractors and corporate partners, and provide regulatory support for various departments, projects, and teams/committees. Successful hire will lead a global regulatory team within Therapeutic Area.
Essential Functions: * Responsible for directing global regulatory strategies for assigned projects and programs integrating regional requirements (US, EU, JP, China, ICH, etc.). * Direct global clinical and pre-clinical regulatory strategies. * Direct global life cycle management of products. * Support development of the late stage clinical development plan. * Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks. * Provide regulatory guidance to company personnel throughout the research and development process. * Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages. * Develop and maintain the Core Data Sheet and lead global labeling team meetings. * Advise on global CTA submission strategy. * Direct the organization and preparation of clear and effective submissions. * Prepare and deliver effective presentations for external and internal audience. * Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs. * Mentor Regulatory Leads and guide direct reports in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports. * Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. * Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
* 10 years of U.S. & EU regulatory affairs experience in the biopharmaceutical industry with a progression of responsibility * Demonstrated experience with regulatory submissions for gene therapy based products * Direct experience leading filings for biological products with the MAA/MHRA. * Demonstrated experience as primary contact with the MAA/MHRA as evidenced by leading Agency meetings, leading Agency presentations and serving as point of contact * Demonstrated management experience including: o Development and administration of policies and procedures for a regulatory affairs department o Key member of an experienced and successful project team o Successful management of outside consultants o Strategic and tactical regulatory skills; and the ability to connect the two * Demonstrated ability to lead an effective regulatory team and ensure professional development of team members * Strong leadership skills with demonstrated ability to gain organizational support for ideas * Collaborative style and persuasive interpersonal skills; ability to influence others; positive team player * Creative and innovative with strong conceptual skills; strategic thinking and analytical problem solving ability
The Global Regulatory Franchise Lead - Ophthalmology will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for programs in inherited Retinal Diseases. The lead programs will include a retinal gene therapy for choroideremia, a gene therapy for XL retinitis pigmentosa and a third program for a macular dystrophy. As such, the role requires a strong understanding of the approval pathway for products in the retinal disease space.