Strategic Planning Identifies future directions for Regulatory Writing and works with the Executive Leadership Team to establish business goals for the service lineUnderstands industry dynamics and can 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 Certara Synchrogenix
2. Thought Leadership
Serve as a Subject Matter Expert and represent Synchrogenix at conferences and in professional forumsDevelops and maintains a strong understanding of applicable international guidance documents, regulations, and industry standards and expectationsEnsures Certara Synchrogenix’ operational team alignment with our market strategy and thinking in their project execution and client interactionsServes as a subject matter expert in key client interactions and industry events
3. Client Experience
Able to identify new opportunities and leverage Synchrogenix talent and technology to expand business offerings, strengthen and expand ongoing client relationships, and create new onesEnsures that integrated business processes lead to increased client satisfaction and repeat businessMonitors and participates in overall direction, strategy, and performance standards for Project Leaders and 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 objectives
Education, Experience, Training, and Knowledge :
12+ years of relevant experience and MS degree or better preferred
Minimum of 10 years of experience in a regulatory affairs area within the biopharmaceutical industry or a Contract Research Organization (CRO) environment
Add customer value by demonstrating extensive knowledge of the drug development and regulatory submissions process across the major markets (e.
g., FDA, EMA, PMDA, NMPA)
Prior experience leading global teams and effectively managing staff across multiple projects / programs
Experience developing strategic customer partnerships
Demonstrated leadership skills growing and developing global team
Skills & Abilities :
Recognizes key contacts within the regulatory community and finds ways to make exclusive connections
Monitors competitors and their strategies and recommends appropriate actions internally to maintain a competitive position.
Identifies external best practices, adapting knowledge to work. Works to
achieve internal and external credibility regarding industry knowledge.
Is self-motivated and solution-driven
Will confront unfamiliar situations with confidence and optimism, both technical and interpersonal
Promotes a culture of open communication and respect in a fast-paced, changing environment
Provides individuals with development opportunities to test their capabilities and achieve higher levels of performance, but is also a team player who enjoys collaboration
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.