Regulatory Affairs Manager - Remote, West Coast

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Posted 5 days ago United States Salary undisclosed
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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 Regulatory Affairs Manager you will provide regulatory affairs strategy technical/project leadership over a region(s). 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: Provides technical/project leadership over a region(s), providing innovative solutions including regulatory affairs expertise and clientinterface 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: * Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements. * Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects ofmoderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. * Ensures quality performance for key/managed projects. * Manages project budgeting/forecasting functions. * Identifies and recognizes 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. * Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. * Provides matrix/project leadership, training and guidance to junior team members. Ensures compliance with relevant organizational and regulatory SOPs and WPDs. * Participatesin launch meetings, review meetings and project team meetings. 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 9 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. Knowledge, Skills and Abilities: * Excellent English language (written and oral) communication skills as well as local language where applicable * Excellent attention to detail and quality as well as excellent editorial/proofreading skills * Exceptional 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 * Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects * Excellent 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 * Excellent 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; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc. * Superb understanding of medical terminology, statistical concepts, and guidelines * Excellent analytical, investigative and problem-solving skills * Excellent understanding of budgeting and forecasting PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.) Employees hired in this role may be assigned to a US government contract and if so would be subject to COVID-19 vaccination and reporting requirements