Overview
Job Overview :
The Senior Director of Regulatory Services Mgmt. will develop and grow the service line to support and strengthen Certara's position as a thought leader and a premium technology-enabled service provider in the industry. The Director of Regulatory Services Mgmt. will serve as a primary subject matter expert to the market and maintain oversight of all services within the service line, including operations oversight to drive effective, efficient and high-quality delivery. In addition, the Director of Regulatory Services will liaise with Account Management to identify key future directions and business opportunities.
Responsibilities
Identifies future directions in the supported Service Line and works with the Executive Leadership Team to establish business goals for the service line
Understands industry dynamics and is able to internally communicate, using multiple channels, to facilitate changes through tangible initiatives, creating long-term solutions supporting evolution and growthProvides advice and counsel to senior management on appropriate project / processes to streamline project coordination and decision-makingMonitor competitors and their strategies and take appropriate action to ensure our market position is maintainedDrive the implementation of the corporate framework within CertaraThought LeadershipServe as a Subject Matter Expert and represent Certara at conferences and in professional forums
Develops and maintains a strong understanding of applicable international guidance documents, regulations, and industry standards and expectationsEnsures Certara's operational team alignment with our market strategy and thinking in their project execution and client interactionsServes as a subject matter expert in key client interactions3. Customer Engagement Team Oversight
Participates or leads continuous process improvement with the Clinical or Nonclinical / CMC Writing teams to ensure improved productivity and quality delivery
Accountable for leveraging technology to enable improved delivery and productivityPartners with cross functional service leaders to create lead generation, acquire new customers, support governance, and assure appropriate project executionCoaches and mentors internal staff to enable continued professional development and growth of expertise4. Client Experience
Able to identify new opportunities and leverage Certara talent and technology to expand business offerings, strengthen and expand ongoing client relationships, and create new ones
Ensures that integrated business processes lead to increased client satisfaction and repeat businessMonitors and participates in overall direction, strategy and performance standards for Project Managers / Project Directors / project teamsEnsures services provided to clients are compliant with company policies, procedures, SOPs, ICH-GCPs, client contractual expectations and country specific regulatory requirementsCoordinates with senior management to assure projects are meeting corporate and client objectivesQualifications
Skills & Abilities :
Recognizes key contacts within the regulatory community and finds ways to make exclusive connectionsMonitors competitors and their strategies and recommends appropriate actions internally to maintain competitive position. Identifies external best practice, adapting knowledge to work. Works to achieve internal and external credibility regarding industry knowledge.Is self-motivated and solution-drivenWill confront unfamiliar situations with confidence and optimism, both technical and interpersonalPromotes a culture of open communication and respect in a fast-paced, changing environmentProvides individuals with development opportunities to test their capabilities and achieve higher levels of performance, but is also a team player who enjoys collaborationEducation, Experience, Training, and Knowledge :
10+ years of relevant experience and MS degree or better preferredMinimum of 8+ years of experience in a regulatory affairs area within the biopharmaceutical industry or a Contract Research Organization (CRO) environmentAdd customer value by demonstrating extensive knowledge of the drug development and regulatory submissions processAbility to lead global teams and effectively manage staff across multiple projectsDemonstrated leadership skills growing and developing a teamCertara bases all employment-related decisions 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.