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.

We are looking for a Senior Regulatory Affairs Specialist to join our Regulatory Compliance Review (RCR) team in Bulgaria.

This role requires experience in clinical trials, study start-up, and essential document review.

Major Responsibilities:

• Perform global regulatory compliance review of essential documents supporting the start of clinical studies

• Respond to RCR reviewers/submitters on queries on essential documents

• Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams

• Ensure effective management and coordination of the Regulatory Compliance Review Process

• Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

• Responsible for tracking RCR approvals

• Point of contact for RCR reviewers

• Responsible for updating and posting of the RCR reviewers list

• Responsible for updating and posting of the RCR Compliance Review forms and posting on the RCR home page

• Assist in development and validation of country-specific review forms for new countries, revision, and validation of existing review forms as necessary

• Assist in the organization of the training of RCR reviewers, when required

• Assist in development and tracking of RCR metrics

• Support the organization of ongoing communication and training amongst the RCR reviewers’ group

• Where required/applicable, assist in project specific RCR processes and training of the RCR reviewers’ group

• Other duties as required

Qualifications: 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 5 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:

∙ Strong English language (written and oral) communication skills as well as local language where applicable

∙ Solid attention to detail and quality as well as strong editorial/proofreading skills

∙ Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments

∙ Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

∙ Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

∙ Solid negotiation skills

∙ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables

∙ Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, MDD, publishing, etc.

∙ In certain RA specialty groups e.g. CMC and MDD, will be responsible for authoring technical documents and may provide CMC and MDD subject matter expert support to project teams

∙ Solid understanding of medical terminology, statistical concepts, and guidelines

∙ Strong analytical, investigative and problem-solving skills

∙ Working knowledge of budgeting and forecasting

Management Role: No management responsibility

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. #Start Your Story 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.