[Hiring] Senior Country Approval Specialist @Thermo Fisher Scientific

Role Description

Join Us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation. The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

• 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 global submission strategy.
• Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
• Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
• Act as a key-contact at country level for all submission-related activities.
• Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.
• 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 company’s target cycle times for site activations.
• Prepare the regulatory compliance review packages, as applicable.
• Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
• Oversee country study files and ensure that they meet PPD WPD’s or client SOP’s.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Direct/mentor other SIA individuals assigned to support projects of responsibility, as appropriate.
• Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate.

Qualifications

• 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.

Requirements

• 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.
• Good judgment and decision-making skills.
• Basic medical/therapeutic area and medical terminology knowledge.
• Ability to work in a team environment or independently, with minimal supervision, as required.
• Ability to mentor fellow SIA team members in a positive and effective manner.
• Excellent team player with teambuilding skills.
• Basic organizational and planning skills.
• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations.

Working Conditions and Environment

• Work is performed at home (remote position).

Benefits

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.