Now Hiring – Executive Director, Global Regulatory Affairs Strategy

We are a diverse and highly passionate team of professionals focused on one goal: getting life-changing and lasting therapies into the patients who need them most. We are looking for a Regulatory Affairs Strategy Leader dedicated to Public Health, passionate about gene therapy development, and committed to making a difference in the lives of millions of patients, who can’t wait. The leader is expected to develop and execute a regulatory strategy for overcoming the obstacles to obtain product approvals faster and smarter. We strongly encourage professionals working on ocular drug/gene therapy, especially in rare or ocular diseases to apply.

Internal Interfaces:

• Reports to: Senior Vice President Regulatory and Quality
• Coordinates with: Chief Scientific Officer, Chief Medical Officer/ Clinical Development Officer, VP-CMC, Head-Quality, Lead-Biostatistics / Data Management, Lead-Clinical Operations, Project Management

External Interfaces:

• Regulatory Bodies; Health Authorities; Vendors/Suppliers, CDMOs, Contract Research Organizations; SME-Consultants.

Key Responsibilities:

Regulatory:

• Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for pipeline
• Provides strategic regulatory advice on the clinical/commercial development of gene therapy products, including interpretation of final and draft regulatory guidance regarding specific ophthalmic disease therapeutic targets
• Keeps abreast of new developments in gene therapy and maintains oversight on the rapidly evolving regulatory landscape and advancing innovations in the development of gene therapy
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide the team
• Is a leader in the department, contributing to cross-functional initiatives and influencing the field as applicable
• Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings
• Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance
• Ensures project team colleagues, line management, and key stakeholders are appraised of any developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
• Proactively anticipates risks and is responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of success for the solutions
• Accountable for US FDA and EMA submissions and approvals of project(s) of responsibility
• Direct point of contact with health authorities, leads and manages FDA/EMA meetings
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided to local affiliates in compliance with local regulations and to maintain compliance for products
• Establishes close working relationships with vendors and contractors for regulatory activities and submissions related to projects
• Participates with influence in or leads departmental and cross-functional task forces and initiatives
• Partners with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable
• Monitors and anticipates trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
• Reviews the work of colleagues for content and quality to ensure the expectations are met
• Guides project team members and acts as a mentor to junior staff; deputizes for the line manager for the day-to-day coordination and management of staff as instructed.

Other Responsibilities

• Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of Nanoscope are met
• When applicable, serves as a leading member of industry association boards, task forces, and committees and/or as chairperson or officer of one or more professional associations
• Contributes expertise to professional societies, academic or other similar groups influential in his/her area of expertise
• Facilitates resolutions to possible problems or conflicts within the project team

Qualifications

• Executive Director must be an internationally recognized professional in their field of expertise with experience with major filings and product approvals
• Minimum of an advanced degree in a scientific or technical discipline or PhD preferred, or equivalent experience
• 15+ years of pharmaceutical industry experience, inclusive of 10+ years of regulatory experience
• Understanding of the regulatory framework for the clinical development of gene therapy products leading to global marketing authorizations or alternatively for the clinical development of Rare Disease drugs
• Solid working knowledge of drug development process and regulatory requirements
• Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity, and adaptability; must be able to manage effectively projects or deliverables towards organizational or team goals in a complex environment
• Demonstrates acceptable skills with increasing independence in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
• Must work well with others and within global teams and able to bring working teams together for common objectives
• Willingness to travel to various meetings, including overnight trips and up to 25% domestic/ international travel may be required in the future
• Must be able to interface with subject matter experts including Consultants effectively
• Must have worked cross-functionally intra-organizationally and extra-organizationally in-person, through MS Teams/Skype/Zoom/WebEx sessions, and developing relationships within and outside of the company.