Thermo Fisher Scientific is a global leader in advancing science to make the world healthier, cleaner, and safer. With clinical trials conducted in over 100 countries and a dedication to innovative research, Thermo Fisher Scientific delivers life-changing therapies and solutions to some of the world’s most critical health challenges. The organization fosters an environment that prioritizes integrity, intensity, innovation, and involvement, creating a collaborative culture that values diversity and empowers employees to achieve their potential.

Responsibilities in Job

As a Senior Regulatory Affairs Specialist on the Bulgarian FLEX team, your role will encompass a range of responsibilities:

• Prepare documentation and submissions under the European Union Clinical Trials Regulation (EUCTR) guidance.
• Coordinate and manage client deliverables to ensure regulatory compliance.
• Liaise with internal and external clients to track project plans and provide status updates.
• Maintain a strong understanding of Standard Operating Procedures (SOPs), client-specific directives, and current regulatory guidelines.
• Evaluate client needs concerning project timelines, quality, and delivery.
• Collaborate with project team members, functional units, and management to deliver final products and address any issues.
• Provide project-specific services, including documentation and coordination, while supporting reporting to clients and management.
• Assist in preparing bids, proposals, contract modifications, and bid defenses.
• Gain expertise in labeling requirements and support related projects.

Qualifications

To succeed as a Senior Regulatory Affairs Specialist, the following qualifications are required:

• Educational Background: Bachelor’s degree or equivalent in a relevant field.
• Experience: 2-3 years of prior experience in a related role. A combination of education, training, and relevant experience may also be considered.
• Regulatory Knowledge: Basic understanding of global, regional, and national regulatory procedures for clinical trial authorization, licensing, and lifecycle management.
• Medical Terminology: Familiarity with medical terms, statistical concepts, and relevant guidelines.

Skills

The ideal candidate will demonstrate the following skills:

• Proficiency in English (written and oral) and local languages, where applicable.
• Excellent attention to detail and proofreading capabilities.
• Strong interpersonal skills for effective teamwork.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and adaptability to new technologies.
• Organizational and time-management skills to meet deadlines.
• Analytical and problem-solving abilities.

What We Offer

Thermo Fisher Scientific provides a comprehensive benefits package aimed at supporting the health and well-being of its employees. Highlights include:

• Competitive salary.
• Flexible work culture promoting a healthy work-life balance.
• Award-winning learning and development programs to ensure career growth.
• A collaborative and inclusive environment where colleagues share expertise and celebrate success together.
• Global opportunities with a local feel, fostering a sense of belonging.

Application Link

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