Regulatory Affairs Intern (1 year fixed-term contract)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.

Regulatory Affairs Intern (12-Month Internship with Potential for Extension)

Location: Sofia, Bulgaria Clinical Research Business Business Center Megapark

Working Hours: 6 hours per day, 4 days in office + 1 remote day per week

About the Role:

We are seeking a motivated Regulatory Affairs Intern to join us on a 12-month internship, with the potential for extension or transition to a permanent position based on performance and business needs.

This is a unique opportunity to launch your career within one of the world’s leading CDMO–CRO organizations. You will gain exposure to a variety of Regulatory Affairs functions across our Clinical Research Organization, with a primary focus on supporting our Regulatory Intelligence, Policy, and Advocacy (RIPA) team.

We offer a flexible, learning-oriented environment designed to accommodate university schedules and help you build the skills, experience, and professional confidence needed to thrive in a global organization.

Major responsibilities:

• Act as an administrator for in-house Regulatory Intelligence database.
• Proactively monitor the global regulatory environment for regulatory intelligence updates to support the regulatory intelligence screening process.
• Supply to Regulatory Intelligence database content projects including hyperlink repair, reformatting.
• Act as system workflow user according to SOPs.
• Quality check review of the information in Regulatory Intelligence database for readability, consistency, and accuracy against regulatory agency guidance.
• Supports business development activities by downloading reports from Regulatory Intelligence database, and/or seeking input from in-country associates.
• Proactively communicate with in-country associates to ensure global regulatory intelligence
• Effectively communicate with vendors for regulatory intelligence updates
• Authoring of Regulatory Intelligence Bulletins and Newsletter
• Generate MS PowerPoint slides, reports in MS Excel and MS Word, and provide administrative assistance as required by RIPA management.

Qualifications:

Education and Experience:

- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

- Currently a 3rd or 4th-year undergraduate, master’s student, or recent graduate in a relevant discipline.

- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year) - in a regulatory, scientific, or administrative role is an advantage.

- In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

• Good organizational and planning skills

• Capable of working effectively on a team and/or independently

• Good electronic document production skills

• Good IT proficiency including experience using Microsoft Office software

• Good attention to detail and quality of documentation

• Good interpersonal skills with the ability to interact well with colleagues

• Solid verbal and written communication skills

• Capable of multitasking

Why Join Us?
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a difference in the world. This internship offers hands-on experience in regulatory operations within a global, mission-driven company committed to innovation and improving lives.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.