Senior Country Approval Specialist

Thermo Fisher Scientific•Morrisville, NC

2d•Onsite

About The Position

The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy. This role involves providing local regulatory strategy advice, developing and implementing local submission strategies, and serving as the primary contact for investigators and local regulatory authorities. The specialist ensures adherence to guidelines and processes for effective communication and timely management of submissions. They also coordinate with internal departments to align site start-up activities with submission timelines and achieve company targets for site activations. Additionally, the role involves preparing regulatory compliance review packages, liaising with local teams to ensure alignment with global strategies, developing country-specific patient information and informed consent documents, and assisting with grant budgets and contract negotiations. The specialist also supports feasibility activities, maintains trial status information, oversees country study files, and stays updated on relevant SOPs and regulatory guidelines. They may also direct and mentor other team members and proactively identify and resolve regulatory issues.

Requirements

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).
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

Nice To Haves

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.

Responsibilities

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 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/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.