Country Approval Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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.

What Youll 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 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 companys 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 that they meet PPD WPDs or client SOPs.
Maintain knowledge of and understand PPD SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided.
Direct/mento 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.

Education & Experience Requirements:
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 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
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 in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear garments and gloves.

Why Join Us

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

Apply today to help us deliver tomorrows breakthroughs.

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1