Senior Director – Head of RA

Senior Director – Head of RA

Requirements

• MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
• Proven success in regulatory submissions
• FDA, US, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP’s, FDA, and US guidelines
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or US oral explanations/scientific advice, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• CRO management experience preferred
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
• Must be a strong leader that creates a vision for group
• Must be strong overall and able to train/develop staff in the area of 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
• Strategic thinker, planner, and implementer with excellent organizational skills
• Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables
• Demonstrates potential for a high level of collaboration with others and within global teams
• Independent thought, negotiation skills, integrity, and adaptability
• Ability to work on own and in virtual setting
• MS Office skills with excellent use of excel, PowerPoint and MS Project required
• Fluent in English (written and oral)

Responsibilities

• Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan
• Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects
• Ensures compliance for global regulatory requirements
• Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors
• Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
• Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications
• Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies
• 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 global submissions and approvals of project(s) and/or oversees direct reports responsible
• Oversees all submissions
• Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations
• 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

Preferred Qualifications

• Recent experience with a smaller entrepreneurial environment is a definite asset
• CRO management experience preferred