Hybrid Regulatory Affairs Job at Thermo Fisher, Italy
Are you looking to build a career in regulatory affairs within the life sciences industry? The Regulatory Affairs Specialist I position at Thermo Fisher Scientific offers professionals the opportunity to work with global regulatory teams and ensure product compliance with international standards. In this Regulatory Affairs Job at Thermo Fisher Careers in Italy, you should support the regulatory submission process that helps bring scientific innovations to market.Â
About the Company:
Thermo Fisher Scientific is a global leader in serving science, providing innovative technologies, analytical instruments, and laboratory solutions that help make the world healthier, cleaner, and safer. The company supports scientists, healthcare professionals, and organizations worldwide in advancing research, improving diagnostics, and developing life-saving therapies.
With a strong commitment to innovation and quality, Thermo Fisher Scientific works on solving some of the world’s biggest challenges, including environmental protection, food safety, and disease treatment. Its global teams collaborate across research, manufacturing, and regulatory functions to deliver reliable products and services to customers worldwide.
Job Details:
- Job Title: Regulatory Affairs Specialist I
- Location: Ferentino, Frosinone, Italy
- Job Type: Full-Time
- Work Model: Hybrid
- Department: Quality & Regulatory
- Job ID: R-01344800
- Work Schedule: Monday – Friday
- Work Environment: Office
Key Responsibilities:
- Manage product registrations and regulatory submissions across international markets in this Regulatory Affairs Job at Thermo Fisher Career.
- Compile and maintain technical documentation required for regulatory compliance.
- Review global regulatory requirements to ensure products meet international standards.
- Support product lifecycle management from initial registration to post-market activities in Regulatory Affairs in Italy.
- Collaborate with Quality Assurance, MSAT, Commercial teams, and regulatory authorities.
- Maintain regulatory documentation and ensure accurate compliance records.
- Assist in preparing and reviewing regulatory dossiers and submission files in Regulatory Affairs Job at Thermo Fisher Careers.
- Facilitate efficient product launches by ensuring regulatory approvals are maintained.
Educational Requirements for this Job:
Candidates applying for this position should meet the following requirements:
- Bachelor’s Degree in a scientific discipline such as Life Sciences, or related scientific fields
- Additional qualifications in Quality Management or Regulatory Affairs are considered advantageous.
Skills Required:
- Experience with regulatory submissions and documentation management.
- Strong technical writing and documentation skills.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
- Knowledge of GMP, ISO 13485, and quality management systems.
- Strong analytical and problem-solving skills.
- Excellent organisational abilities and attention to detail.
- Effective written and verbal communication skills in English.
- Ability to work both independently and within cross-functional teams.
- Experience with regulatory databases and submission systems (preferred).
- Strong project management skills and ability to meet deadlines.
- Customer-focused mindset with strong interpersonal skills.
Benefits of the Regulatory Affairs Job:
- Opportunity to work on global regulatory projects.
- Exposure to international regulatory compliance and product registration processes.
- Career development opportunities within a leading life sciences company.
- Collaboration with global cross-functional teams in Quality, Regulatory, and Commercial departments.
- A hybrid work model provides flexibility.
- Access to learning resources and professional development programs.
- Opportunity to contribute to scientific innovations that improve healthcare and safety worldwide.
