Director, Clinical Regulatory Affairs

Thermo Fisher Scientific•Morrisville, NC

3d•Onsite

About The Position

The Director Regulatory Affairs provides operational leadership for the department, overseeing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. The role involves managing projects and participating in strategic initiatives, and acting as liaison with internal and external clients in the provision and marketing of regulatory services. What You'll Do: Manage staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime. Promote all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assure department adherence to good ethical and regulatory standards. Provide regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products. Provide project specific strategy, technical expertise and coordination oversight for key client’s projects. Serve as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensure quality performance for key/managed projects. Oversee project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget. Lead and participate in project meetings. Ensure identification of out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modification. Collaborate with business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD. Actively engage in business development activities looking to attract collaborative and stand-alone projects. Pursue existing clients who have a need for services to win more business. Contribute to development and implementation of global/regional function/plans. Ensure compliance with relevant organizational and department SOPs and WPDs Develop strategy and lead the development and implementation of processes and procedures to increase productivity and accuracy within the team. Participate in developing and implementing systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements, reduction in cycle times, submission activities, metrics and other key performance indicators.

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years).
5+ years of management responsibility
Strong leadership skills
Superior English language communication and negotiation skills, as well as local language where applicable, both oral and written
Excellent understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management; superior understanding of ICH and other global regulatory guidelines; advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC, publishing, etc.
Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills
Capable of supervising, evaluating, and mentoring departmental personnel, as well as delegating tasks and facilitating the completion of assignments
Capable of driving innovation in developing new ideas related to process improvements
Excellent organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
Capable of independently learning new technologies
Capable of effectively acting as a liaison with other departments

Responsibilities

Manage staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations.
Approve courses of action on salary administration, hiring, corrective action, and terminations.
Review and approve time records, expense reports, requests for leave, and overtime.
Promote all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan.
Assure department adherence to good ethical and regulatory standards.
Provide regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products.
Provide project specific strategy, technical expertise and coordination oversight for key client’s projects.
Serve as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions.
Ensure quality performance for key/managed projects.
Oversee project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget.
Lead and participate in project meetings.
Ensure identification of out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modification.
Collaborate with business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD.
Actively engage in business development activities looking to attract collaborative and stand-alone projects.
Pursue existing clients who have a need for services to win more business.
Contribute to development and implementation of global/regional function/plans.
Ensure compliance with relevant organizational and department SOPs and WPDs
Develop strategy and lead the development and implementation of processes and procedures to increase productivity and accuracy within the team.
Participate in developing and implementing systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements, reduction in cycle times, submission activities, metrics and other key performance indicators.