Regulatory Affairs Manager – Clinical Trial Applications
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇮🇹 Italy
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Lead the preparation of global regulatory submissions and ensure high quality standards that meet local and regional requirements.
- Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity.
- Provides internal clients with up-to-date legislation and guidance as it becomes available.
- Ensure quality performance for key/managed projects.
- Manage project budgeting/forecasting functions.
- Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications.
- Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments.
- Provides matrix/project leadership, training and guidance to junior team members.
- Ensure compliance with relevant organizational and regulatory SOPs and WPDs.
- Participate in launch meetings, review meetings and project team meetings.
Requirements
- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job, at least 5 years
- Proven project management experience, and experience performing effectively in a client facing role
- 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
- Excellent analytical, investigative, and problem-solving skills
- Excellent understanding of budgeting and forecasting
Benefits
- Competitive salary
- Extensive benefits package
- Award-winning learning and development programme
- Flexible working culture, valuing work-life balance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementregulatory submissionsbudgetingforecastingcomplianceanalytical skillsproblem-solvingeditorial skillsproofreadingregulatory affairs procedures
Soft skills
communication skillsinterpersonal skillsorganizational skillstime managementplanning skillsnegotiation skillsattention to detailteam collaborationindependent judgmentclient-facing skills
Certifications
Bachelor's degreeadvanced degree