Director, Regulatory Affairs - CMC biologics

We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to Managers and consulting employees, actively managing performance and development. You will succeed in this role thanks to your extensive Regulatory Affairs CMC experience, strong leadership, innovative thinking and ability to embrace changes.

Key Accountabilities:

• Project Execution: Monitor the profitability of multiple projects, prepare project plans, and manage project budgets. Proactively avoid and resolve issues with revenue recognition. Provide guidance to project team members and act as a mentor to junior staff. Prioritize workloads and achieve project scope and objectives. Improve project efficiency, results, and team performance.

• Staff Management: Actively manage performance, provide input on staff, support the management of their staff, facilitate staff development plans, and coordinate with project staffing to increase resource utilization and profitability. Provide leadership, coaching, mentoring, feedback, and role modeling to managers and extended staff. Communicate and champion organizational vision and values.

• Consulting Activities and Relationship Management: Plan and deliver services and solutions that result in client satisfaction and build relationships. Identify opportunities for follow-on business, act as a trusted advisor to clients, and implement business solutions addressing specific client needs. Interact professionally at multiple levels, including senior management within client organizations.

• Business Development: Actively prospect and leverage new business opportunities with clients and industry contacts. Present information about the company service offerings, deliver customized sales presentations, and actively engage in bid defense meetings. Generate new or repeat business due to personal name recognition or history of client satisfaction and/or relationship.

Skills, Knowledge, and Experience required for the role:

• Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD preferred)

• Numerous years of experience in the life sciences or consulting industries with many years of experience managing people and projects

• Extensive technical knowledge in CMC biologics; vaccines would be a plus

• Experience in people management and development

• Ability to influence others

• Client-focused approach to work

• Business acumen and analysis, including budgeting and forecasting

• Excellent interpersonal and intercultural communication skills

• Critical thinking and problem-solving skills

• Operational leadership

• Strategic business thinking