The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Manages a large, regional and/or global team of staff and managers within the department and provides 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. Manages projects and participates in strategic initiatives. Acts as liaison with internal and external clients in the provision and marketing of regulator
Manages 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.
Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.
Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products.
Provides project specific strategy, technical expertise and coordination oversight for key client’s projects. Serves as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projects.
Manages 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. Leads and participates in project meetings.
Ensures identification of out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modification.
Collaborates 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.
Contributes to development and implementation of global/regional function/plans.
Ensures compliance with relevant organizational and department SOPs and WPDs
Creates and leads the development and implementation of processes and procedures to increase productivity and accuracy within the team. Participates 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 indicatory services
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 10+ years).
5+ years of management responsibility
Proven leadership skills
Experience with Advanced Therapies
Internal Number: 192951
About Pharmaceutical Product Development (PPD)
At PPD, our purpose is to improve health, our mission is to help our customers deliver life-changing therapies and our strategy is to bend the cost and time curve of drug development and optimize value.