Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.  

Our Regulatory Affairs Department is looking for a Principal Regulatory Affairs Assistant to become a part of the Bulgarian FLEX team. As a Regulatory Affairs Specialist you will be provide administrative and coordination support to Regulatory Affairs Leads who provide regulatory advice with regards to global regulatory services for clinical trial submission dossier preparation on global level. You will assist in compiling and providing project specific documentation, support in coordination of projects, reporting, conducting File review and working with different systems.

Principal Regulatory Affairs Assistant (FLEX)

Major Responsibilities:

-Supports timely collection and management of data, metrics, experience statements for regulatory affairs documentation.
-Provides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients.
-Supports the preparation of documentation and regulatory submissions under guidance.
-Coordinates and manages client deliverables supporting regulatory compliance.
-Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
-Engages other project team members, functional units and/or management as
necessary to deliver final product, and resolve/mitigate identified issues or
barriers to delivery as needed.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

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:

Experience with regulatory submissionsGood English language (written and oral) communication skills as well as local language whereapplicableGood attention to detail and quality as well as editorial/proofreading skillGood interpersonal skills to work effectively in a team environmentGood computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologiesBasic organizational, time management, and planning skillsBasic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle managementBasic understanding of medical terminology, statistical concepts, and guidelinesGood analytical, investigative and problem-solving skillsCapable of interpreting data

What we offer:

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

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.

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.