.**JOB DESCRIPTION**:We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.As a Senior Regulatory Affairs Specialist, you will provide innovative regulatory solutions to our clients.At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.Summarized Purpose:Serves as a senior contact in providing innovative solutions including regulatory expertise, interacting with clients to provide strategic regulatory 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.Essential Functions:- Prepares and reviews regulatory submissions.- Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.- Leads the development and implementation of project-specific processes for sponsors.- Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.- Provides training and guidance to junior team members as appropriate.- Participates in project launch meetings, review meetings and project team meetings.- Supports business development activities, including project budgeting/forecasting.**Job Qualification**:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).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
