Senior Reg Affairs Specialist (FLEX)

Standard (Mon-Fri) Office 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 Sr Regulatory Affairs Specialist to become a part of the Bulgarian FLEX team. As a Sr Regulatory Affairs Specialist you will be providing regulatory advice and carry out projects in the provision of regulatory affairs services. Senior Reg Affairs Specialist (FLEX)

• Supports the preparation of documentation and submissions under EUCTR guidance.
• Coordinates and manages client deliverables supporting regulatory compliance.
• Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects.
• Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
• Evaluates client needs in relationship to overall project timelines, quality and delivery.
• Engages with 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
• Provides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients.
• Supports preparation of bids and proposals; generates, tracks and analyses data for proposal, revisions, contract modifications and bid defenses.
• Labelling Experience

Education and Experience:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-3 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:

• Good English language (written and oral) communication skills as well as local language where
• applicable
• Good attention to detail and quality as well as editorial/proofreading skills
• Good interpersonal skills to work effectively in a team environment
• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Basic organizational, time management, and planning skills
• Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
• Basic understanding of medical terminology, statistical concepts, and guidelines
• Good analytical, investigative and problem-solving skills