Regulatory Country Approval Specialist

Description

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.

Essential Job Functions/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 strategyProvide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clientsProvide project specific local SIA services and coordination of these projectsMay have contact with investigators for submission related activitiesKey–contact at country level for either Ethical or Regulatory submission–related activitiesCoordinates, 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 activationMay work with the start–up CRA(s) to prepare the regulatory compliance review packages, as applicableMay develop country specific Patient Information Sheet/Informed Consent form documentsMay assist with grant budgets(s) and payment schedules negotiations with sites.Support the coordination of feasibility activities, as required, in accordance with agreed timelinesEnter and maintain trial status information relating to SIA activities onto tracking databases in an accurate and timely mannerEnsure the local country study files and filing processes are prepared, set up and maintained as per WPDs or applicable client SOPsMaintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicableRequired knowledge, skills and abilities:

Knowledge of all applicable regional / national country regulatory guidelines and EC regulationsEffective oral and written communication skillsExcellent interpersonal skillsStrong attention to detail and quality of documentationGood negotiation skillsGood computer skills and the ability to learn appropriate softwareGood English language and grammar skillsSome basic medical/therapeutic area and medical terminology knowledgeAbility to work in a team environment or independently, under direction, as requiredDisclaimer:

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.

Ad ID: 5417148081