Our client a specialty pharma company focused solely on Ophthalmology, and innovating therapies to improve the quality of life for patients worldwide. This single focus in ophthalmology enables them to challenge unmet needs in the field—through passionate research, successful collaboration, and clarity of commitment.
With over 130 years of investigative insight, they remain committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, they are expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Their clinical development network spans three continents, with centers in Europe, Japan, and the United States.
The Sr. Director of Global Regulatory Affairs (Sr. Director) is responsible for the planning, integrating and developing their regulatory strategy and managing regulatory activities, leading to rapid approval of their products and/or appropriate maintenance of marketed products. This is a hands-on leadership role and will provide strategic and operational leadership for the direction, planning, execution and conduct of regulatory objectives, projects and submissions. This position will lead a U.S. regulatory team of six; a two Sr. Regulatory Specialists, two Sr. Regulatory Affairs Specialists and a Regulatory Affairs Manager, and a Director, Regulatory Affairs.
The Sr. Director will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Specific responsibilities include:
Provide strategy for US and Canadian registration of their Products and occasionally the integration of US strategy into a global regulatory strategy on global projects.
Provides strategic and tactical advice to the team to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
Is a leader within the company and external to the company contributing to cross-functional initiatives and influencing the field as applicable.
Provides leadership and development for six (6) direct reports.
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Sr. Director will lead all submission types.
Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings.
Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local the company affiliates in compliance with local regulations and to maintain compliance for products.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
Responsible for demonstrating company leadership behaviors.
The successful candidate must be a skilled relationship developer, employ an entrepreneurial spirit, and passionately embody the company mission.
Bachelor’s in a scientific field required; Advanced Degree preferred.Minimum 5+ years successful management experience.
10+ years of experience in regulatory affairs with specific focus on FDA and Health Canada.
15+ years of experience in the pharmaceutical or biotech industry (ophthalmic experience preferred).
Experience developing staff/people.
Effective negotiation and decision making skills.
Direct experience negotiating with the FDA.
Experience in pre-approval inspections.
Experience in registration of sterile products.
Experience leading project teams.
Experience managing regulatory professionals.
Thorough knowledge of GMPs, GLPs, GCPs, ICH guidelines, and US regulatory guidelines.
Working knowledge of EU and Japanese regulations.
Proficient at intermediate level with Microsoft Office suite of software.
Excellent written, verbal and presentation skills.
Demonstrated ability to collaborate cross-functionally.
Proven track record of effective planning and organizational skills.
Ability to originate and complete projects with little to no oversight.
Ability to interact successfully with multiple diverse cultures.
Additional Salary Information: Base, bonus, LTI and equity