Job Description

: PPD, part of Thermo Fisher Scientific 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 thousands of professionals worldwide, PPD, part of Thermo Fisher Scientific 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. See below for an exciting opportunity to join our Regulatory Affairs as Regulatory Affairs Specialist position We are vital links between an idea for a new medicine and the people who need it, We are the people of PPD, part of Thermo Fisher Scientific - thousands of employees 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. Summarized Purpose 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. As a Regulatory Affairs Specialist you will be providing regu latory advice and acts as liaison with internal and external clients in the provision and marketing of these services. Responsibilities : Works with the Regulatory Affairs Management to perform the day-to-day operational aspects of the Department such as: preparation and assembly of global regulatory submissions unassisted, intercting with sponsors, review and assess regulatory documents,review and assess scientific literature. Interfaces with PPD project teams, sponsors, and Health Authorities regarding regulatory strategy/ submission activities. Develops and maintains a cooperative working relationship with Project Managers and project team members for assigned projects. Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities. Acts as primary liaison between Regulatory Affairs Department and project team for assigned protects. Essential Functions: Supports the preparation of documentation and submissions under guidance. Coordinates and manages client deliverables supporting regulatory compliance. Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. Assists in business development and pricing of projects for the department. Evaluates client needs in relationship to overall project timelines, quality, and delivery. Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed. Job Qualification: Education and Experience: Bachelor\'s degree or equivalent and relevant formal academic /vocational qualification. Degree in Pharmacy or Life Science is an advantage. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years), or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered Knowledge, Skills and Abilities: Previous experience with clinical trials application compilation and submissions in EU, APAC and other regions is an advantage Excellent 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 and interpersonal skills to work effectively in a team environment Solid 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 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 An appreciation of the requirements, timelines and processes for regulatory applications worldwide is an asset Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization and other global regulatory guidelines of regulatory speciality areas, such as licensing, lifecycle management, CMC, publishing, is an advantage. Basic understanding of medical terminology, statistical concepts, and guidelines Good analytical, investigative, and problem-solving skills Capable of interpreting data

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