Regulatory Country Approval Specialist

Overview

Are you an experienced Regulatory Country Approval Specialist? Do you have experience managing the preparation, review and coordination of Country Submissions? If so, this could be the perfect opportunity for you!

We are recruiting for Regulatory Country Approval Specialist to join a globally leading CRO that provides comprehensive drug development and laboratory services to accelerate the delivery of new therapies to market.

This role is offered on a contract basis initially for 6 months, Inside IR35 with a remote set up.

Responsibilities

• Prepare, review and coordinate, under guidance, 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, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
• Provide project specific local SIA services and coordination of these projects
• May have contact with investigators for submission related activities
• Key-contact at country level for either Ethical or Regulatory submission-related activities
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
• May develop country specific Patient Information Sheet/Informed Consent form documents
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines
• Enter and maintain trial status information relating to SIA activities onto 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 WPDs or applicable client SOPs
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable

Required knowledge, skills and abilities

• Knowledge of all applicable regional / national country regulatory guidelines and EC regulations
• 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
• Some basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required

Disclaimer

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited (\”ARM\”). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.