The Regulatory Operations Specialist is responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within (and around) Europe. This is a team and individual contributor role, reporting to the Manager of Regulatory. This position will work collaboratively with regulatory, country CRA and project team. This position requires a strong technical background, a high degree of enthusiasm, enjoyment of working in a fast-paced environment, being self-motivated, and being able to use critical reasoning to solve problems and make decisions.
What You’ll Do:
Under the supervision of the European Regulatory Manager:
Performs the role of a Regulatory Lead for studies within the European region during study start-up until study close out
Oversees and performs 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)
Performs 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
Oversees, coordinates 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
Performs 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
Prepares the clinical trial application within CTIS for Part I with supervision; in compliance with forecasted timelines
Escalates 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
Responsibilities may differ slightly from the above based on specific needs of the business.
Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
What We Look For:
Experience needed for the Role:
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
Additional Skills & Attributes:
Competency in Microsoft Office applications, especially Word
Ability to work well in a team environment, have a strong commitment to the accomplishment of tasks, can follow procedures, and has the initiative to identify opportunities for improvements and the inter-personal skills to promote and accomplish constructive solutions to problems.
Ability to work in a fast-paced environment
Attention to detail with emphasis on accuracy and quality
Ability to prioritize work to balance multiple projects and deadlines
Excellent verbal and written communication skills
Experience updating and reviewing PIS/ICF templates
Familiarity with the clinical trial process and regulatory submissions regulations and guidelines within Europe
Familiarity with ICH-GCP standards
Competencies and Personal Traits:
Attention to Detail: Ability to analyze data to drive successful solutions to complex problems.
Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy.
Intellectual Curiosity: Willingness and desire to learn new things and dig deeper than the surface.
Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again.
Organization and Goal Setting: Ability to set goals, develop structure and maintain a focused approach to critical path work.
Resolve Conflicts: Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.
What We Offer:
Financial: Competitive salaries along with a structured pension plan.
Well-Being: Offering private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth.
Company Paid Life & Disability Insurance: Offering peace of mind through Canada Life to help you and your family feel secure.
PTO: 25 days of annual leave + Birthday PTO + bank holidays.
Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
Career Development Opportunities: Continued opportunities to grow and develop your career journey.
Global Team: Opportunities to work with colleagues across the globe.
Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.
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