Senior Regulatory Affairs Specialist (Regulatory Compliance Review)

Work Schedule

Environmental Conditions

Job Description

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

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:

-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 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 100000 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.

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