Associate Director, Regulatory Consulting - Gene/Cell Therapy
Posted on Apr 5, 2021 by INC Research
Responsible for the effective and efficient management of Global Regulatory Consulting and Submissions (GRC) functions under assigned span of control. Responsible for the leadership and management of regulatory personnel and assuring that the various departmental tasks are completed in conformity with all the policies, Standard Operating Procedures, directives, and governmental regulations. Contributes to business development for regulatory functions, planning of staff and locations, and budgets; develops goals objectives, plans, and procedures, in conjunction with the senior management.
Contributes to planning for the GRC function in assigned region/country.
Contributes to the development of policies, goals, objectives, plans, and procedures for GRC functions under assigned span of control.
Responsible for day to day management of their teams, and projects. Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
Acts as a representative of the regulatory department with other departments.
Supports business development, including generation of repeat business from existing clients, introduction of new clients, and proposal development.
Contributes to the development and maintenance of budgets for regulatory functions under span of control.
Develops, reviews, and monitors project budgets.
Reviews client invoicing and utilization rates.
Acts as a key point of contact for clients, regulatory authorities, and senior managers within the Company.
Provides regulatory advice to all associates.
Provides strategic and operational advice to clients.
Prepares consulting reports.
Reviews/writes critical strategic sections of documents prepared for clients.
Arranges, leads, and reports on client and regulatory agency meetings, providing managerial supervision as necessary.
Manages project teams and preparation of regulatory submissions for conduct of clinical trials, product registration, and post approval maintenance activities.
Acts as a resource for industry and technical knowledge.
Leads and participates in quality improvement efforts to increase overall operational efficiency.
Manages the building of the regulatory systems and infrastructure needed for global RCS.
Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
Assists with identification of external sources of expertise and arranging collaboration as necessary.
Develops solutions to complex problems.
Contributes to design of training programs and train staff as needed.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Post-graduate qualification in relevant discipline, such as regulatory, drug development, biotechnology, or equivalent regulatory experience.
Candidates with previous cell and/or gene therapy experience are strongly preferred.
Extensive pharmaceutical/medical device related experience.
Moderate experience in regulatory. Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, CTA, MAA, and CTD, including electronic submissions.
Experience working in an independent office environment, and in a complex multi-process oriented environment in general preferred.
Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development. Knowledge of the CRO industry.
Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently. Excellent written and verbal communication skills.
Good quality management and budgeting skills.
Good people management, project management, problem-solving, and decision-making skills.
Computer literacy in MS Word, Excel, and PowerPoint.
Ability to interact with staff from multiple departments and offices to establish project standards.
Good initiative, adaptability, and pro-activity. Good attention to detail, flexibility, and open to suggestions.
Years of experience required: Minimum of twelve (12) years of pharmaceutical/medical device related experience and minimum of eight (8) years of regulatory experience.