Senior Regulatory Affairs Specialist (FLEX)

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.

• 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 ofproject plans and overall support of projects.
• Maintains knowledge and understanding of SOPs, client SOPs/directives, andcurrent regulatory guidelines.
• Evaluates client needs in relationship to overall project timelines, quality anddelivery.
• Engages with other project team members, functional units and/or management asnecessary to deliver final product, and resolve/mitigate identified issues orbarriers 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:

• Bachelor's 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.