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 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 applicableRequired 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 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