Regulatory Affairs Specialist - CTA (Clinical Research Field)

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.Location/Division Specific Information(Currently is seeking a Senior/Regulatory Affairs Specialist to join our growing Regulatory Affairs department - Regulatory science team. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field.Regulatory Affairs Specialist - CTA (Clinical Research Field)In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services.You’ll work 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, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature. You will also act as primary point of contact for the sponsors of assigned projects.Responsibilities:Supports the preparation of documentation and CTA 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, qualityand 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.What the role requires you to have:Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job of at least 2 yearsExperience with regulatory submissionsKnowledge of the global clinical trials landscapeProven project management experience, and experience performing effectively in a client facing roleKnowledge, Skills and Abilities:Excellent command of the English language (written and oral) as well as local language where applicableExcellent attention to detail and quality as well as excellent editorial/proofreading skillsExceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departmentsAdvanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologiesStrong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projectsExcellent negotiation skillsCapable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverablesExcellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelinesExcellent analytical, investigative and problem-solving skillsUnderstanding of budgeting and forecastingWhat we offer:As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.