FSP Country Approval Specialist

ThermoFisher Scientific; Roma; Ibrido; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific in Rome, Italy seeks a Country Approval Specialist to manage and coordinate local regulatory submissions in line with global strategy. You will provide regulatory strategy guidance to internal clients and support start-up activities at the country level.

Key responsibilities include coordinating MoH/EC submissions, maintaining SOP-aligned country files, and ensuring site activation timelines align with submission plans.

Competenze

• Bachelor's degree or equivalent with relevant formal academic qualification.
• Experience or knowledge enabling local regulatory submissions and coordination.
• Familiarity with MoH/EC regulatory processes and documentation.

Mansioni

• Prepare, review and coordinate local regulatory submissions (MoH, EC, etc.) in line with EU/global strategy.
• Provide local regulatory strategy advice to internal clients.
• Coordinate start-up services and project activities related to submissions.
• Serve as country-level contact for submission-related activities.
• Coordinate with internal departments to align site start-up activities with submission timelines.

Conoscenze

Effective communication

Interpersonal skills

Attention to detail

Negotiation

Computer skills

English proficiency

Medical terminology

Team collaboration

Formazione

Bachelor's degree or equivalent

Strumenti

MS Office

Descrizione del lavoro

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Country Approval Specialist and make an impact at the forefront of innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What you will do:

• Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with EU/global submission strategy

• Provide local regulatory strategy advice (MoH &/or EC) to internal clients

• Provide project specific local start-up services and coordination of these projects

• May have contact with investigators for submission related activities

• Serve as key-contact at country level for either Ethical or Regulatory submission-related activities

• Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation

• Achieve target cycle times for site activation

• Prepare the regulatory compliance review packages, if applicable

• Develop country specific Patient Information Sheet/Informed Consent form documents

• May assist with grant budget(s) and payment schedules negotiations with sites

• May support the feasibility activities, as required, in accordance with agreed timelines

• Enter and maintain trial status information relating to start-up activities onto the study specific tracking databases in an accurate and timely manner

• Ensure the local country study files and filing processes are prepared, set up and maintained as per applicable SOPs

• Maintain knowledge of and understand SOPs, client directives, and current regulatory guidelines as applicable to services provided

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+ 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:

• Effective oral and written communication skills

• Excellent interpersonal skills

• Strong attention to detail and quality of documentation

• Good negotiation skills

• Good computer skills and the ability to learn appropriate software

• Good English language and grammar skills

• Basic medical/therapeutic area and medical terminology knowledge

• Ability to work in a team environment or independently, under direction, as required

• Basic organizational and planning skills

• Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations

Working conditions and environment:

• Work is performed in an office environment

• Exposure to electrical office equipment

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.