The Senior Director of Regulatory Writing will be a key operational leader in Company’s-, tasked with growing the Regulatory Writing service lines to support and strengthen company’s position as a high-quality organization and as the preeminent technology-enabled service provider in the industry.
Must have the business acumen as well- looking at productivity and profitability as well as the strong regulatory writing expertise
The group is part of a large global leader but this team is in huge expansion and need strong Leader to work along with the Executive Vice President (tons of growth potential for this role)
1.They will serve as the primary subject matter expert to the market and maintain oversight of all services within Regulatory Writing, leading to 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: • Strategic Planning • Identifies future directions for Regulatory Writing and works with the Executive Leadership Team to establish business goals for the service line • Understands industry dynamics and can internally communicate, using multiple channels, to facilitate changes through tangible initiatives, creating long-term solutions supporting evolution and growth • Provides advice and counsel to senior management on appropriate project/processes to streamline project coordination and decision-making • Monitor competitors and their strategies and take appropriate action to ensure our market position is maintained • Drive the implementation of the corporate framework within Company2.Thought Leadership • * • * Serve as a Subject Matter Expert and represent Company at conferences and in professional forums • Develops and maintains a strong understanding of applicable international guidance documents, regulations, and industry standards and expectations • Ensures Company’ operational team alignment with our market strategy and thinking in their project execution and client interactions • Serves as a subject matter expert in key client interactions
3.Client Experience :* Able to identify new opportunities and leverage Company 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 business • Monitors and participates in overall direction, strategy, and performance standards for Project Leaders and Project Teams • Ensures services provided to clients are compliant with company policies, procedures, SOPs, ICH-GCPs, client contractual expectations, and country-specific regulatory requirements • Coordinates with senior management to assure projects are meeting corporate and client objectives
Education, Experience, Training, and Knowledge: Must be comfortable working remotely (US Headquarters and offices are in DE, NJ and NC)
• 10+ years of relevant experience and MS degree or better preferred • Minimum of 8 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 a 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