Senior Country Approval Specialist
Posted 22 days ago
You'll complete your application on Thermo Fisher Scientific's career site.
About the Role
This senior-level position is vital for managing regulatory filings and maintaining adherence to international and regional benchmarks. You are expected to orchestrate local regulatory tactics, offer specialized technical guidance, and act as the main point of contact between regulatory bodies and investigators. By synchronizing local operations with overarching submission goals, you will facilitate the effective execution of pharmaceutical and research initiatives, contributing to the advancement of science and patient care. Working within an international team, you will engage with cross-functional groups to handle site initiation tasks and ensure projects remain on schedule. You will tackle sophisticated regulatory hurdles, provide mentorship to colleagues, and impact project outcomes through careful management and forward-thinking planning. Additionally, you will be key in preserving the accuracy of trial records and verifying that all regulatory procedures are meticulously followed to satisfy project objectives.
Requirements
- You must hold a bachelor's degree or an equivalent academic credential.
- A minimum of five years of related professional experience is required.
- You need exceptional verbal and written communication skills, with professional fluency in English.
- You must exhibit meticulous attention to detail to uphold documentation standards and show sound judgment and decision-making abilities.
- You should possess foundational knowledge of medical terminology and therapeutic areas, alongside superior planning and organizational talents.
- You are required to have an expert grasp of relevant national and regional regulatory policies and EC directives.
- Strong technical literacy is necessary, including the ability to master specific software applications, as well as the capacity to perform effectively both autonomously and in a team setting.
Responsibilities
- You will draft, examine, and organize regional regulatory filings while offering strategic regulatory counsel to internal partners.
- You will function as the main country-level representative for submission tasks, interacting with investigators and local officials.
- You will create patient information sheets and informed consent documents tailored to the country, while managing site initiation to meet cycle-time objectives.
- You will manage study documentation at the country level to guarantee total alignment with standard operating procedures and keep trial status updates precise in the tracking system.
- You will participate in budget discussions regarding grants, provide guidance to teammates, troubleshoot regulatory challenges, and attend project briefings to keep local tasks aligned with the global strategy.
Benefits & Perks
- The position is entirely remote, offering flexibility in your workspace while adhering to standard full-time working hours.
- You will benefit from working alongside a worldwide team of professionals and gain access to various internal growth and training opportunities.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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