Provides strategic leadership to achieve the Company’s mission and goals, creating value for customers. Focuses on billable work, customer relations and business development of the Company’s regulatory services. Leadership of other functional areas may be required per the direction of the executive management. Develops and mentors staff and provides leadership to the Company. Responsible for employee issues, administrative functions, and budgetary responsibilities related to the Regulatory Affairs business. Travel to current and prospective client sites and Company global offices, as needed.
- Develops and implements strong customer-focused business/marketing plans and establishes partnerships with customers. Builds new business through customer contacts and networking. Develops strong relationships with current and prospective clients to generate new and/or add-on business.
- Maintains ultimate accountability for the quality of client deliverables. Provides strategic guidance and tactical oversight for selected engagements.
- Responsible for meeting personal utilization target and, where applicable, team or group targets.
- Participates in Company community initiatives and demonstrates broader Company collaboration with the Regulatory Affairs business unit, as well as across the organization.
- Line management responsibilities for staff members (if applicable). For direct and indirect reports, may participate in and manage activities related to department staff operations. Approves courses of action on salary administration, hiring, corrective action, and terminations for assigned team.
- Defines, develops, and implements standards, procedures, and protocols and evaluates processes and services against those standards.
- Prepares and maintains department budgets, with direction of line manager. Monitors utilization and expenditures to ensure staffing is appropriate for work required and that fiscal goals are met.
- Prepares the organization for new or changing regulations.
- Through publications and presentations, builds recognition of the Company’s expertise in the Regulatory Affairs and Product Development Strategy.
- Performs other work-related duties as assigned.
- Moderate travel may be required (up to 50%).
- PhD/PharmD/MD in a scientific discipline or equivalent combined education and experience preferred.
- Extensive clinical development and/or pharmaceutical industries experience, with emphasis on interactions with regulatory agencies and hands-on experience managing programs from development through the approval process.
- Extensive leadership experience in drug development and regulatory affairs. Moderate experience in clinical research. Demonstrated expertise in several areas of clinical product development: chemistry, manufacturing, and controls development, non-clinical development, and/or clinical development.
- Experience with biologics, gene therapy, medical devices and/or advanced medicinal products.
- Extensive knowledge of country specific regulations and medical terminology.
- Leadership skills to provide direction to, and foster teamwork across, numerous projects operating out of regional office and the corporate functional areas.
- Strong leadership and organizational skills to manage the departments profitably while focusing on the customers’ needs.
- Managerial skills to develop short and long-range business plans, identify and implement effective workflow processes and procedures, and manage budget and work execution.
- Interpersonal skills to foster open communication.
- Ability to coach and develop others, and to act as a catalyst for positive change.
- Proficiency in Microsoft Office Suite and email.