Regulatory Operations Specialist II

Job not on LinkedIn

🕒 May 13

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Ora

WebsiteLinkedInAll Job Openings

201 - 500 employees

Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, we have proudly helped our clients earn more than 85 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

📋 Description

• Responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within (and around) Europe. • Performs the role of a Regulatory Lead for studies primarily 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) and other submissions portal(s), as required. • 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 finalisation. • 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 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. • Adhere to all aspects of Ora’s quality system. • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.

🎯 Requirements

• Bachelor’s degree in applied or life science/healthcare or other related, scientific field • 3 years of experience in 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 • Efficient use of 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 the EU • Familiarity with ICH-GCP standards • Multi-lingual communication is a plus.

🏖️ Benefits

• Competitive salaries along with a structured pension plan. • Offering private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth. • Offering peace of mind through Canada Life to help you and your family feel secure. • 25 days of annual leave + Birthday PTO + bank holidays. • We'll reimburse you to support your remote workspace and wellness purchases. • Continued opportunities to grow and develop your career journey. • Opportunities to work with colleagues across the globe. • A chance to research new ophthalmic therapies that will impact patients across the globe.