The Sr. Director Regulatory Strategy will provide strategic regulatory guidance and tactical support to further the progress of our client’s development programs and will bring additional depth and breadth in regulatory strategy to our team. This role will provide regulatory input into specific development programs and into asset assessment through the Due Diligence process. The role will also provide advice to project teams on current and evolving regulatory guidance documents from global health authorities and participate in cross-functional peer review of development projects, thereby providing added value to the business mission by ensuring state of the art input on client projects.
Serve as a regulatory strategist subject matter expert (SME) in key client interactions. Lead, manage, and coordinate strategic regulatory consulting and stewardship activities to clients, supporting a variety of global regulatory activities.
Develop and implement regulatory strategies to support preparation and filings of INDs, CTAs, NDAs, MAAs, and defense of those applications.
Ensure compliance with global regulatory requirements. and oversee critical deliverables.
Write, review, and provide strategic regulatory guidance on complex regulatory documents and alternative pathways, such as fast track, breakthrough therapy (and other expedited programs), orphan, and 505(b)(2), and corresponding pathways in Europe. Review content for regulatory submissions from other disciplines to ensure high quality and relevance for intended objectives.
Manage and coordinate responses to address regulatory agencies requests.
Participate in the review of product labelling to support filing for new or additional indications.
Write, review, and provide strategic regulatory guidance on pediatric development plans.
Lead cross-functional drug development and pediatric drug development teams (internal and external [client]).
Assure projects are meeting client objectives, and deliverables are of high quality, on time, and within budget.
Proactively anticipate and mitigate regulatory risks while maintaining current knowledge of regulatory procedures, changes, and trends.
Provide strategic and thorough due diligence input, including positive aspects, risks and overall probability of success
Maintain leading edge awareness of key regulations and guidances affecting overall drug approval processes. Awareness of regulatory trends and potential impact on product development in the US, Europe, and Japan
Develop and maintain effective relationships with regulatory agency personnel, regulatory experts, and consultants to optimize regulatory outcomes.
Coach and mentor other colleagues regarding the drug development and pediatric drug development regulatory landscape.
Provide support for the continuing expansion the Integrated Pediatric Practice Area.
Serve as a regulatory strategist SME and represent Certara at conferences and in professional forums.
Business Development and Internal Support
Interface and work closely with key consulting leaders in planning new business development activities and executing projects
Assist in strengthening business development activities by expanding ongoing client relationships and identification of new clients and contributing to and or independently developing project proposals.
Support key corporate initiatives with regulatory insights
Develop and maintain training, policies, and procedures for full regulatory compliance and best practices
Education, Experience, Training, and Knowledge:
Bachelor’s in a in a relevant life science discipline required. Master’s or PhD is preferred.
12+ years of global experience in regulatory within the biotech or pharmaceutical industry, consulting experience a bonus.
A strong understanding of applicable international guidance documents, regulations, and industry standards and expectations to support drug (eg, small molecules and biologics, and combination products) development and pediatric drug development. Highly conversant and knowledgeable of ICH, GMPs, GLPs and GCPs, and new and emerging regulations and guidances in the US and EU; experience in JP and China a plus.
Solid understanding of where to seek and how to interpret regulatory information.
Experience providing strategic regulatory advice to support global drug development through all stages of development including pre-approval and marketed compounds.
Track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical/biotech compounds
Advisory committee hearing experience a plus
Skills & Abilities:
Excellent understanding of the drug development process
Ability to build effective relationships with health authorities as well as with internal stakeholders and employees.
Desire to improve the research and development ecosystem by executing innovative development solutions / approaches for clients and patients
Demonstrated ability to influence peers proactively and effectively, and external colleagues across all levels of management
Self-starter, independent and a practical thinker, strong and passionate team leader
Ability to manage complex issues and coordinate multiple projects simultaneously.
Excellent written, verbal, and inter-personal communications skills
Strong client and alliance management skills
Ability to work across functions to implement company initiatives
Must be able to work well with a team in a multidisciplinary environment
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.