PPD Regulatory Affairs Specialist / Senior Regulatory Affairs Specialist - office or home based in Morrisville, North Carolina
Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. 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 2 years).
Knowledge, Skills and Abilities:
Good English language (written and oral) communication skills as well as local language where applicable
Good attention to detail and quality as well as editorial/proofreading skills
Good interpersonal skills to work effectively in a team environment
Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
Good negotiation skills
Capable of working independently with direction and exercising independent judgment
Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables
Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
Basic understanding of medical terminology, statistical concepts, and guidelines
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Frequently stationary for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
/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./
*Job: Regulatory Affairs
*Organization: Clin Dev-United States (CLDUS)
*Title: Regulatory Affairs Specialist / Senior Regulatory Affairs Specialist - office or home based
*Location: North Carolina-Morrisville - Home Based
*Requisition ID: 144047
*Other Locations: North America-United States