Mantell Associates is currently partnered with a large, leading, heavily funded international CRO, in their search for a Country Approval Specialist/Submissions Specialist based in Belgium.
Are you looking to join a leading international CRO?
Do you want to work for a fully funded CRO with state of the art equipment?
The CRO we are partnered with are one of the Top 10 Large CRO's on the planet and have an office in the heart of Belgium, Brussels. This organisation has one of the lowest staff turnover and highest employee retention rates in the CRO space due to their constant career progression, welcoming culture and buzzing business environment.
Country Approval Responsibilities:
- Prepare, evaluate, and organise local regulatory submissions (MoH, EC, and any extra special national local applications, if appropriate, such as gene therapy approvals, viral safety dossiers, and import licences) in accordance with the global submission plan under direction.
- Provide internal clients with local regulatory strategy advice (MoH &/or EC) under supervision.
- Provide project-specific local SIA services and project coordination.
- Investigators may have to be contacted for submission-related activity.
- Key point of contact for Ethical or Regulatory Submission-related actions at the country level.
- Coordinate with internal functional departments, with direction, to ensure that various site start-up activities are aligned with submissions activities and mutually agreed-upon dates; ensures that the submission process for sites and studies is connected to the essential route for site activation.
- As needed, you may collaborate with the start-up CRA(s) to produce regulatory compliance review packages.
- You may create Patient Information Sheets/Informed Consent Forms that are customised to each nation.
- You might be able to help with grant budgeting and payment plan talks with the locations.
- As needed, assist in the coordination of feasibility operations in accordance with agreed-upon timescales.
- Input and maintain correct and timely trial status information linked to SIA operations into PPD tracking systems.
- Assist in the preparation, setup, and maintenance of local country study files and filing processes in accordance with PPD WPDs or appropriate client SOPs.
- Maintain a working awareness of and understanding of PPD SOPs, Client SOPs/directives, and current regulatory norms as they pertain to the services delivered.
Country Approval Specialist/Submissions Specialist requirements:
- 0 – 2 years of relevant experience, or an equivalent mix of education, training, and experience.
- Excellent interpersonal skills.
- Exceptional attention to detail and documentation quality.
- Good computer skills and the ability to learn appropriate software.
- Fluency in English and either Dutch or French.
- Basic medical/therapeutic knowledge as well as medical terminology.
- Knowledge of all applicable regional/national country regulatory norms as well as EC regulation is required.
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Lewis Joshi on +44 (0)2038547700 or firstname.lastname@example.org