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Regulatory Operations Specialist II

2 months ago

Amman, Amman, Jordan Ora, Inc Full time
About the Job

Ora, Inc is seeking a highly skilled Regulatory Operations Specialist II to join our team. As a key member of our Regulatory Operations team, you will be responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within Europe.

Key Responsibilities
  • Perform the role of a Regulatory Lead for studies within the European region during study start-up until study close out.
  • Oversee and perform quality control checks on clinical and regulatory documents, including Patient Information Sheet (PIS)/Informed Consent Form (ICF).
  • Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS).
  • Perform quality control checks on study documents that are received from the sponsor and/or prepared by country CRAs to ensure all submission documents meet Ora's submission standards.
  • Oversee, coordinate and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalization.
  • Contributes to the review and revision of standard operating procedures (SOPs), templates, and forms.
  • Perform data entry for tracking of regulatory submission activities.
  • Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents are filed in collaborative workspace.
  • Prepare the clinical trial application within CTIS for Part I with supervision; in compliance with forecasted timelines.
  • Escalate potential issues identified to impact forecasted timelines quickly.
  • May be required to provide regulatory support in other regions.
  • Keep up to date with current regulations, guidelines and changes in the industry.
  • Collaboration with Global Regulatory team and wider stakeholders.
Requirements
  • Bachelor's degree in applied or life science/healthcare or equivalent.
  • 3 years of medical, regulatory, or clinical experience or equivalent training and work experience, including coursework.
  • Experience with clinical research including overseeing or making submission in a country or region.
  • Understanding of Clinical Trial Information System (CTIS) and EU CTR.
What We Offer
  • Competitive salaries along with a structured pension plan.
  • Private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth.
  • Company Paid Life & Disability Insurance.
  • 25 days of annual leave + Birthday PTO + bank holidays.
  • Remote & Wellness Reimbursement.
  • Career Development Opportunities.
  • Global Team.
  • Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.