PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
The Global Regulatory Affairs Services department provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.
As a Regulatory Affairs Director you will provide direct management and support to members of Regulatory Affairs Development. You are responsible for all budgets and contracts in relation to their assigned projects. You are the executive contact for the sponsor.
This position offers continued career advancement working from an office or from home within the Global Regulatory Affairs Services department or other departments within PPD.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.
Provides technical/project leadership globally, providing 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. Provides updates to personnel as required on country/regional/global regulatory intelligence, strategic regulatory authority updates, and acts as advisers to other units within the department, as well as any local country regulatory authorities. Acts as liaison with internal and external clients in the provision and marketing of these services.
Education and Experience:
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
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Mastery of English language (written and oral) communication skills as well as local language where applicable
Exceptional attention to detail and quality as well as outstanding editorial/proofreading skills
Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
Effective organizational, time management, and planning skills to create and follow timelines,conduct long-range planning, adapt to changing priorities and handle multiple projects
Professional negotiation skills
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH
and other global regulatory guidelines; in-depth understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
Advanced understanding of medical terminology, statistical concepts, and guidelines
Outstanding analytical, investigative and problem-solving skills
Excellent understanding of budgeting and forecasting
Sharp executive presence and consultation and presentation skills
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Telecommuting is allowed.
Additional Salary Information: tbd
Internal Number: 152284
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.