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Principal Reg Affairs Specialist - Roma, Italia - Thermo Fisher Scientific
Descrizione
Principal Reg Affairs Specialist (Remote) Principal Reg Affairs Specialist | Thermo Fisher Scientific |ItalyJob Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a... Login to continue At Thermo Fisher Scientific, you'll discover meaningful work that makes apositive impact on a global scale. Join our colleagues in bringing ourMission to life – enabling our customers to make the world healthier,cleaner and safer.
We provide our teams with the resources needed toachieve individual career goals while taking science a step beyond throughresearch, development and delivery of life-changing therapies.
Withclinical trials conducted in 100+ countries and ongoing development ofnovel frameworks for clinical research through our PPD clinical researchportfolio, our work spans laboratory, digital and decentralized clinicaltrial services.
Your determination to deliver quality and accuracy willimprove health outcomes that people and communities depend on – now andin the future.
We are currently seeking a Principal Regulatory Affairs Specialistto join our global Regulatory Affairs department – RegulatoryScience team. This is a fantastic opportunity to further develop yourregulatory career and expertise in a global clinical trial setting.On this role you will be a pivotal team member with regulatory affairsresponsibilities, leading discussions, and coordinating regulatorystrategies globally on assigned (Phase 1 to 4) clinical trials, studies andprojects.
You will be part of a global team providing innovative solutions and globalregulatory expertise, being client interfacing to provide strategicregulatory intelligence and guidance.
You will feel confident providing regulatory advice and carry out projectsin the provision of regulatory affairs services whilst acting as liaisonwith internal and external clients.
You will act as a representative of the regulatory department with otherdepartments, supporting business development, working on initiatives, andcontributing to quality improvement.
You will also arrange, lead, andreport on client and regulatory agency meetings.The following skills are required to be successful in thisposition:
Preparation and assembly of global regulatory submissionsInteracting with sponsors,Review and assess clinical trial regulatory documents,Review and assess scientific literature.
Manage project teams and preparationParticipate in launch meetings, review meetings and project teammeetingsExperience with bid defense meetingsEducation and experience:
Bachelor's degree or advanced degree preferred, or equivalent andrelevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities toperform the job around 8+ yearsExpert knowledge of the global clinical trials landscapeKnowledge, Skills and Abilities:Excellent command of the English language (written and oral) as well aslocal language where applicableExcellent attention to detail and quality as well as excellenteditorial/proofreading skillsExceptional interpersonal skills to work effectively in a team environmentand act as a liaison with other departmentsAdvanced computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologiesStrong organizational, time management, and planning skills to create andfollow timelines, conduct long-range planning, adapt to changing prioritiesand handle multiple projectsCapable of working independently and exercising independent judgment toassess sponsor regulatory needs and work with project team members toproducing compliant deliverablesExcellent understanding of global/regional/national countryrequirements/regulatory affairs procedures for clinical trialauthorization; expert knowledge of ICH and other global regulatoryguidelinesExcellent analytical, investigative and problem-solving skillsWhat we offer:As well as being rewarded a competitive salary, we have an extensivebenefits package based around the health and well-being of our employees.
We have a flexible working culture, where PPD Clinical Research Servicestruly value a work-life balance.We've grown sustainably year on year butcontinue to offer a collaborative environment, with teams of colleagueseager to share expertise and have fun together.
We are a globalorganisation but with a local feel.Our Mission is to enable our customers to make the world healthier, cleanerand safer. Watch as our colleagues explain 5 reasons to work with us.
Asone team of 100,000+ colleagues, we share a common set of values –Integrity, Intensity, Innovation and Involvement – working togetherto accelerate research, solve complex scientific challenges, drivetechnological innovation and support patients in need.
#StartYourStory withPPD, part of Thermo Fisher Scientific, where diverse experiences,backgrounds and perspectives are valued.Apply today Fisher Scientific is an EEO/Affirmative Action Employer and does notdiscriminate on the basis of race, color, religion, sex, sexualorientation, gender identity, national origin, protected veteran status,disability or any other legally protected status.
#LI-AS3Tagged as:remote, remote job, virtual, Virtual Job,virtual position, Work at Home, work from home
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