The Country Approval Specialist manages and coordinates local regulatory submissions and provides strategic regulatory advice to internal clients. They also ensure site start-up activities align with submission timelines and maintain accurate trial status documentation.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join us as a Country Approval Specialist and make an impact at the forefront of innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.
What you will 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 EU/global submission strategy
Provide local regulatory strategy advice (MoH &/or EC) to internal clients
Provide project specific local start-up services and coordination of these projects
May have contact with investigators for submission related activities
Serve as key-contact at country level for either Ethical or Regulatory submission-related activities
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 target cycle times for site activation
Prepare the regulatory compliance review packages, if applicable
Develop country specific Patient Information Sheet/Informed Consent form documents
May assist with grant budget(s) and payment schedules negotiations with sites
May support the feasibility activities, as required, in accordance with agreed timelines
Enter and maintain trial status information relating to start-up activities onto the study specific tracking databases in an accurate and timely manner
Ensure the local country study files and filing processes are prepared, set up and maintained as per applicable SOPs
Maintain knowledge of and understand SOPs, client directives, and current regulatory guidelines as applicable to services provided
Education and experience:
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 2+ 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 and 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
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations
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