Country Regulatory Submissions Specialist

ThermoFisher Scientific; Colombia; A distancia; COP 45.000.000 - 65.000.000; Jornada completa

Descripción de la vacante

The Thermo Fisher Scientific team in Colombia is seeking a Country Approval Specialist to manage local regulatory submissions in line with our global strategy. You will prepare, review and coordinate submissions to MoH/EC and related authorities, ensuring alignment with project timelines and country requirements.

In this role you’ll provide regulatory guidance to internal clients, liaise with investigators, and work with cross-functional groups to keep country studies on track and compliant

Formación

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 2+ years of related experience.
• Familiarity with regulatory guidelines and EC regulations.
• Ability to work in a team environment or independently, under direction.

Responsabilidades

• Prepares, reviews and coordinates, under guidance, 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 global submission strategy.
• Provides, under guidance local regulatory strategy advice (MoH /or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPD’s target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Conocimientos

Effective communication

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English language

Medical terminology knowledge

Teamwork

Planning skills

Regulatory guidelines knowledge

Educación

Bachelor's degree or equivalent

Descripción del empleo

The Thermo Fisher Scientific team in Colombia is seeking a Country Approval Specialist to manage local regulatory submissions in line with our global strategy. You will prepare, review and coordinate submissions to MoH/EC and related authorities, ensuring alignment with project timelines and country requirements.

In this role you’ll provide regulatory guidance to internal clients, liaise with investigators, and work with cross-functional groups to keep country studies on track and compliant