Regulatory Affairs Manager (Global Clinical Trial Applications)
Employer · Thermo Fisher Scientific
Licensing officer
Legal specialist
Other health professionalDaytimeFull-timeBudapest
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. We are currently seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department, Regulatory Science team, in a fantastic opportunity to further develop your regulatory career in a global clinical trial setting.
Tasks
- Lead the preparation of global regulatory submissions for CTA 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.
- Provide oversight across multiple studies/projects, ensuring alignment of regulatory strategy, quality, and delivery.
- Act as a senior client-facing lead, contributing to broader regulatory planning and supporting proposals, bid defenses, and scope discussions.
- Ensure quality performance for key/managed projects.
- Manage project budgeting/forecasting functions and maintain accountability for financial and scope management.
- Identify and recognize out-of-scope activities and partner with relevant teams to manage contract modifications.
- Collaborate with business development in pricing and securing new business by contributing to proposals, budgets, and client presentations.
- Provide matrix/project leadership and guidance to team members.
- Ensure compliance with relevant organizational and regulatory SOPs and WPDs.
- Participate in launch meetings, review meetings, and project team meetings.
Conditions & benefits
Competitive salaryRewarded with a competitive salaryBenefits packageExtensive benefits package focused on health and well-beingFlexible working cultureFlexible working culture where work-life balance is valuedGrowth and developmentCollaborative global environment with opportunities for growth and development
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 (comparable to 9+ years)
- Proven project management experience and experience performing effectively in a client-facing role
- Strong understanding of global/regional regulatory requirements and ICH guidelines
- Excellent analytical, investigative, and problem-solving skills
- Solid understanding of budgeting and forecasting
- Excellent English language (written and oral) communication skills as well as local language where applicable
- Excellent attention to detail and quality, with strong 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 Microsoft Word, Excel, and PowerPoint
- Strong organizational, time management, and planning skills
- Excellent negotiation skills