The VP, Regulatory Strategy will have the opportunity to make significant contributions to the Strategy Consultant group by providing strategic regulatory guidance and tactical support to further the progress of our client’s drug development programs and bring additional depth and breadth in regulatory strategy to our team. In this role, you will provide regulatory input for due diligence projects and regulatory input for specific client programs. You will also provide training to project teams on current and evolving regulatory guidance documents from global health authorities and participate in cross-functional peer review of projects where necessary, providing added value to the business mission of ensuring high quality expertise input on client projects.
Lead, manage and coordinate complex strategic regulatory consulting engagements and services to clients, supporting a variety of global regulatory activities
Prepare regulatory deliverables at all phases of development while maintaining close cooperation with regulatory authorities
Ensure compliance with global regulatory requirements. Work to resolve conflicts in regulatory strategies and oversee critical deliverables
Manage and coordinate responses to address regulatory agency requests
Manage and monitor the preparation, assembly and filing of regulatory submissions
Perform thorough due diligence assessments, including risks and success probabilities
Review content for all regulatory submissions from other disciplines to ensure high quality and relevance for intended objectives
Assess preparation requirements, including planning, writing and reviewing of all sections of regulatory submissions, including responses to regulatory requests
Support Business Development engagements in planning new business development activities and executing projects
Develop and maintain effective relationships with regulatory agency personnel, regulatory experts, and consultants to optimize regulatory outcomes
Support key corporate initiatives with regulatory insights
Develop and maintain training, policies and procedures for full regulatory compliance and best practices
Implement regulatory strategies to support development and filings of INDs, NDAs, MAAs, BLAs and defense of those applications for our clients
Maintain leading edge awareness of key regulations guidance affecting overall drug approval process and awareness of regulatory trends and potential changes affecting drug development and approval in global markets (North America, Europe, Asia Pacific Region)
Proactively monitor, analyze, interpret and communicate emerging global regulatory trends, approvals and strategies to inform and influence the development of regulatory strategies and policies both across and within disease therapy areas
Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. The well-being of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:
Financial – competitive pay, incentives, retirement plans, income security programs
Health and Wellness – comprehensive benefit package, wellness programs, healthy lifestyle office environments
Work/Life – unlimited paid time off and an employee assistance program
Growth & Development – performance driven environment
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Education, Experience, Training, and Knowledge:
Master’s or PhD degree in a relevant life science discipline is preferred
12+ years of experience in a regulatory affairs area within the biopharmaceutical industry or a Contract Research Organization (CRO) environment
Global regulatory experience leading teams
Led a team that developed regulatory strategy for drug development
Skills & Abilities:
Track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of drug applications
Experience successfully leading teams through multiple regulatory interactions with global health authorities
Experience in actively participating in a due diligence evaluation
Excellent understanding of the drug development process
Ability to build effective relationships with health authorities as well as with internal and external stakeholders and employees
Demonstrated ability to proactively and effectively influence peers and external colleagues across all levels of management
Excellent writer, verbal and inter-personal communication skills
Ability to work across functions to implement company initiatives
Certara has demonstrated that a modern, state-of-the-art integrated drug development approach, using quantitative methods to inform, guide, and supplant traditional development methods, dramatically improves efficiency and reduces costs.
We work as an integrated part of your team, asking and answering questions, leveraging the most innovative modeling and simulation technologies and providing deep scientific and regulatory acumen to impact the ROI of your R&D investment.
We have helped our partners successfully bring over 250 new drugs to market with an integrated approach including model-informed drug development, regulatory science, and market access solutions.